Trial Outcomes & Findings for Perioperative Warming Measures in Cesarean Delivery (NCT NCT05015582)
NCT ID: NCT05015582
Last Updated: 2026-05-14
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Treatment
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=10 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=6 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 7.60 • n=10 Participants
|
28.16 years
STANDARD_DEVIATION 2.40 • n=6 Participants
|
29.87 years
STANDARD_DEVIATION 6.20 • n=16 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
6 participants
n=6 Participants
|
16 participants
n=16 Participants
|
|
American Society of Anesthesiology (ASA) Classification
ASA I
|
0 Participants
n=9 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
0 Participants
n=6 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
0 Participants
n=15 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
|
American Society of Anesthesiology (ASA) Classification
ASA II
|
5 Participants
n=9 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
3 Participants
n=6 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
8 Participants
n=15 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
|
American Society of Anesthesiology (ASA) Classification
ASA III
|
4 Participants
n=9 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
3 Participants
n=6 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
7 Participants
n=15 Participants • Data were not collected from 1 participant in the treatment arm because the ASA classification was not collected by study personnel for this participant.
|
PRIMARY outcome
Timeframe: preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)Outcome measures
| Measure |
Treatment
n=10 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=6 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Maternal Core Body Temperature
preoperative/beginning of surgery
|
96.48 degrees Fahrenheit
Standard Deviation 1.28
|
96.48 degrees Fahrenheit
Standard Deviation 1.40
|
|
Maternal Core Body Temperature
postoperative/end of surgery (4 hours after anesthesia)
|
97.33 degrees Fahrenheit
Standard Deviation 1.33
|
97.3 degrees Fahrenheit
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)Hypothermia is indicated as core temperature \< 36 °C
Outcome measures
| Measure |
Treatment
n=10 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=6 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Number of Women With Hypothermia
preoperative/beginning of surgery
|
5 Participants
|
2 Participants
|
|
Number of Women With Hypothermia
postoperative/end of surgery (4 hours after anesthesia)
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 minutes after birth, 5 minutes after birthPopulation: Data were collected and analyzed only from participants who had an Apgar score recorded by study personnel on the data collection form at the time after birth.
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Outcome measures
| Measure |
Treatment
n=8 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=2 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score
1 minute after birth
|
8.1 score on a scale
Standard Deviation 0.64
|
8 score on a scale
Standard Deviation 0
|
|
Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score
5 minutes after birth
|
8.6 score on a scale
Standard Deviation 0.51
|
8 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 10 minutes after birthPopulation: Data were collected only from participants who had an Umbilical Artery pH recorded by study personnel on the data collection form at the time of birth.
Outcome measures
| Measure |
Treatment
n=1 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=2 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Umbilical Artery pH
|
7.24 pH
|
7.17 pH
Standard Deviation 0.084
|
PRIMARY outcome
Timeframe: end of surgery (4 hours after anesthesia)Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure. Due to resource limitations, the study team was unable to obtain this data. Specifically, staffing limitations led to the decision to not collect any data from any participants for this Outcome Measure. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]Population: Data were collected only from participants who had a Degree of shivering score recorded by study personnel on the data collection form at on arrival to Post anesthesia Care Unit (PACU) \[about 4 hours after anesthesia\].
Degree of shivering is measured from 0(no shivering)-3(total body shivering), a higher score indicates greater shivering.
Outcome measures
| Measure |
Treatment
n=8 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=5 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Degree of Shivering (Severity)
|
0.5 score on a scale
Standard Deviation 0.75
|
0.2 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: on arrival to PACU [about 4 hours after anesthesia]Outcome measures
| Measure |
Treatment
n=10 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=6 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Number of Patients That Need Meperidine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after 30 minutes in PACUOutcome measures
| Measure |
Treatment
n=10 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=6 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Number of Patients That Need Meperidine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after administration of meperidine, if it applies (about 30 minutes in PACU)Population: Data were not collected for this outcome measure because 0 participants were administered meperidine
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of surgery (4 hours after anesthesia)Population: Data were collected only from participants who had the data recorded by study personnel on the data collection form at the end of the surgery.
Maternal thermal comfort has a total score range from 0 to 10,a higher number indicating more thermal comfort
Outcome measures
| Measure |
Treatment
n=4 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=4 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Maternal Thermal Comfort
|
9.25 score on a scale
Standard Deviation 0.95
|
8.75 score on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: end of surgery (4 hours after anesthesia)Population: Data were collected only from participants who had data recorded by study personnel on the data collection form.
Outcome measures
| Measure |
Treatment
n=9 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=4 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Perioperative Blood Loss
|
688.88 cubic centimeters (cc)
Standard Deviation 145.29
|
675 cubic centimeters (cc)
Standard Deviation 95.74
|
SECONDARY outcome
Timeframe: Time of admission to time of discharge (about 72 hours after surgery)Population: Data were collected only from participants who had data recorded by study personnel on the data collection form. Data were collected from 0 participants in the control arm because no data had been recorded by study personnel due to the personnel being new and not fully trained on how to complete the form. Data collection and analysis for the control arm will not be conducted in the future. Therefore, no participants were measured or analyzed for the control arm.
Outcome measures
| Measure |
Treatment
n=1 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Hospital Length of Stay
|
2 days
|
—
|
SECONDARY outcome
Timeframe: 10 minutes after birthPopulation: Data were collected only from neonates born to mothers with gestational diabetes or pre-existing diabetes.
Outcome measures
| Measure |
Treatment
n=1 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C): upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C): Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C): Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C): IV fluids with hotline fluid warmer set at 42˚C
|
Control Group
n=2 Participants
Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C
Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature
Pre op upper body forced air warming (32˚C): Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C): lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C): fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C): Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperature: IV fluids at room temperature
Intra op upper body forced air warming at (32˚C): upper body forced air warming intra-operative at ambient (32˚C)
|
|---|---|---|
|
Neonate Blood Sugar Level
|
38 mg/dL
|
68 mg/dL
Standard Deviation 22.62
|
Adverse Events
Treatment: Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment: Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stacy Norrell, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place