Trial Outcomes & Findings for Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40 (NCT NCT02984267)
NCT ID: NCT02984267
Last Updated: 2018-07-11
Results Overview
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Assessed immediately during epidural catheter placement
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Ultrasound Group
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ultrasound Group
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
Baseline characteristics by cohort
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 5.5 • n=9 Participants
|
27.9 years
STANDARD_DEVIATION 5.4 • n=16 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=7 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=7 Participants
|
8 Participants
n=9 Participants
|
14 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
Gravidity
|
1 Number of pregnancies
n=7 Participants
|
2 Number of pregnancies
n=9 Participants
|
2 Number of pregnancies
n=16 Participants
|
|
Parity
|
0 Number of children born
n=7 Participants
|
0 Number of children born
n=9 Participants
|
0 Number of children born
n=16 Participants
|
|
Estimated gestational age
|
39.6 Weeks
STANDARD_DEVIATION 0.8 • n=7 Participants
|
38.1 Weeks
STANDARD_DEVIATION 1.1 • n=9 Participants
|
38.7 Weeks
STANDARD_DEVIATION 1.1 • n=16 Participants
|
|
Weight
|
122.0 kg
STANDARD_DEVIATION 17.1 • n=7 Participants
|
120.6 kg
STANDARD_DEVIATION 15.8 • n=9 Participants
|
121.2 kg
STANDARD_DEVIATION 15.8 • n=16 Participants
|
|
Height
|
163.7 cm
STANDARD_DEVIATION 5.3 • n=7 Participants
|
162.1 cm
STANDARD_DEVIATION 5.3 • n=9 Participants
|
162.8 cm
STANDARD_DEVIATION 5.2 • n=16 Participants
|
|
Body mass index
|
45.6 kg/m^2
STANDARD_DEVIATION 7.4 • n=7 Participants
|
45.9 kg/m^2
STANDARD_DEVIATION 6.3 • n=9 Participants
|
45.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=16 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
ASA1
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
ASA2
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
American Society of Anesthesiologists (ASA) physical status
ASA3
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
16 Participants
n=16 Participants
|
|
External landmarks visible
Yes
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=16 Participants
|
|
External landmarks visible
No
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
16 Participants
n=16 Participants
|
|
Palpable interspace
Yes
|
0 Participants
Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
5 Participants
n=9 Participants • Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
5 Participants
n=9 Participants • Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
|
Palpable interspace
No
|
0 Participants
Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
4 Participants
n=9 Participants • Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
4 Participants
n=9 Participants • Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).
|
PRIMARY outcome
Timeframe: Assessed immediately during epidural catheter placementIncludes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Total Time Required for Epidural Catheter Placement
|
6.1 Minutes
Standard Deviation 3.5
|
11.0 Minutes
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Assessed immediately during epidural catheter placementTime required to successfully place the epidural catheter
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Epidural Procedure Time
|
4.33 Minutes
Standard Deviation 3.5
|
10.1 Minutes
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Assessed immediately during epidural catheter placementOutcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Number of Attempts at Epidural Catheter Placement
|
1 Number of attempts
Interval 1.0 to 1.0
|
5 Number of attempts
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Assessed immediately during epidural catheter placementOutcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed immediately during epidural catheter placement and within 24 hours after deliveryAny epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Complications
|
0 Complications
|
4 Complications
|
SECONDARY outcome
Timeframe: Assessed within 24 hours after deliveryAny epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Epidural Failure Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed immediately following epidural catheter placementImmediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Epidural Catheter Placement Satisfaction Level
|
9 Units on a scale
Standard Deviation 1.2
|
7.3 Units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Assessed immediately following epidural catheter placementImmediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Patient Anxiety Level
|
5.4 Units on a scale
Standard Deviation 1.9
|
6.0 Units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Assessed immediately prior to epidural catheter placementThe time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Palpation or Ultrasound Time
|
1.8 Minutes
Standard Deviation 0.6
|
0.9 Minutes
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Measured within 24 hours of deliveryWithin 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
Outcome measures
| Measure |
Ultrasound Group
n=7 Participants
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 Participants
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Overall Anesthesia Experience Satisfaction
|
79.1 Units on a scale
Standard Deviation 11.8
|
74.3 Units on a scale
Standard Deviation 9.4
|
Adverse Events
Ultrasound Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Palpation Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultrasound Group
n=7 participants at risk
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement
|
Palpation Group
n=9 participants at risk
The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement
|
|---|---|---|
|
Injury, poisoning and procedural complications
Inadvertent dural puncture
|
0.00%
0/7 • During the patients current hospitalization (typically 2-3 days)
All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
|
11.1%
1/9 • Number of events 1 • During the patients current hospitalization (typically 2-3 days)
All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
|
|
Injury, poisoning and procedural complications
Paresthesia
|
0.00%
0/7 • During the patients current hospitalization (typically 2-3 days)
All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
|
22.2%
2/9 • Number of events 2 • During the patients current hospitalization (typically 2-3 days)
All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place