Trial Outcomes & Findings for The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities (NCT NCT03876808)
NCT ID: NCT03876808
Last Updated: 2023-10-02
Results Overview
Change in core temperature between induction of anesthesia and end of skin preparation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Day 1
Results posted on
2023-10-02
Participant Flow
Participant milestones
| Measure |
Convective Pre-warming
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities
Baseline characteristics by cohort
| Measure |
Convective Pre-warming
n=6 Participants
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
n=4 Participants
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 19 • n=99 Participants
|
69.5 years
STANDARD_DEVIATION 2.4 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 15.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
30 kg/m^2
STANDARD_DEVIATION 5.7 • n=99 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 12.1 • n=107 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification (PS Class)
ASA PS Class 2
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification (PS Class)
ASA PS Class 3
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Change in core temperature between induction of anesthesia and end of skin preparation
Outcome measures
| Measure |
Convective Pre-warming
n=6 Participants
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
n=4 Participants
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
|---|---|---|
|
Core Body Temperature
|
-0.95 Degrees Celsius
Standard Deviation 0.69
|
-0.53 Degrees Celsius
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Day 1Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU
Outcome measures
| Measure |
Convective Pre-warming
n=6 Participants
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
n=4 Participants
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
|---|---|---|
|
Skin Temperature
Holding area to operating room departure
|
-0.03 Degrees Celsius
Standard Deviation 0.39
|
0.08 Degrees Celsius
Standard Deviation 0.42
|
|
Skin Temperature
Holding area to arrival in PACU
|
-0.07 Degrees Celsius
Standard Deviation 0.67
|
-0.48 Degrees Celsius
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Day 1Core body temperature measured intraoperatively
Outcome measures
| Measure |
Convective Pre-warming
n=6 Participants
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
n=4 Participants
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
|---|---|---|
|
Intraoperative Temperatures
|
36.0 Degrees Celsius
Standard Deviation 0.79
|
35.7 Degrees Celsius
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Day 1Population: In the Standard of care group there were only patients aged 65 years and older. This group also did not receive prewarming aside from blankets, therefore temperature was only recorded once in the preoperative unit.
Differences in temperature changes between elderly (≥ 65 years) and younger patients (\< 65 years).
Outcome measures
| Measure |
Convective Pre-warming
n=6 Participants
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming
3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
|
Standard of Care
n=4 Participants
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
|
|---|---|---|
|
Temperature Differences Between Different Age Groups
Temperature before prewarming - Patients <65 years of age
|
36.5 Degrees Celcius
Standard Deviation 0.2
|
—
|
|
Temperature Differences Between Different Age Groups
Temperature before prewarming - Patients >65 years of age
|
36.6 Degrees Celcius
Standard Deviation 0.6
|
36.5 Degrees Celcius
Standard Deviation 0.4
|
|
Temperature Differences Between Different Age Groups
Temperature after prewarming - Patients <65 years of age
|
36.5 Degrees Celcius
Standard Deviation 0.3
|
—
|
|
Temperature Differences Between Different Age Groups
Temperature after prewarming - Patients >65 years of age
|
36.4 Degrees Celcius
Standard Deviation 0.5
|
—
|
Adverse Events
Convective Pre-warming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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
Dr. Boris Mraovic, Professor of Clinical Anesthesiology
University of Missouri - Columbia
Phone: 573-882-2568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place