Trial Outcomes & Findings for Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models (NCT NCT02742818)
NCT ID: NCT02742818
Last Updated: 2019-12-30
Results Overview
After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.
COMPLETED
NA
50 participants
Across duration of surgery (up to 210 minutes)
2019-12-30
Participant Flow
Participant milestones
| Measure |
Upper Body Blanket
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Upper Body Blanket
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
Baseline characteristics by cohort
| Measure |
Underbody Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
Upper Body Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
70 years
n=7 Participants
|
70.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Across duration of surgery (up to 210 minutes)Population: In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes)
After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.
Outcome measures
| Measure |
Upper Body Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.
|
36.2 Celsius degrees
Interval 35.1 to 37.3
|
36.1 Celsius degrees
Interval 34.3 to 37.1
|
SECONDARY outcome
Timeframe: At time of surgery ( in minutes)The investigators will observe the profile of the patients and the mean of age in two groups.
Outcome measures
| Measure |
Upper Body Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Age ( in Years)
|
70 years
Interval 62.0 to 73.0
|
71 years
Interval 60.5 to 76.5
|
SECONDARY outcome
Timeframe: At time of surgery ( in minutes)The investigators will observe gender distribution in the two groups studied.
Outcome measures
| Measure |
Upper Body Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Gender
Female
|
8 Participants
|
6 Participants
|
|
Gender
Male
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At time of surgery ( in minutes)The investigators will observe the type of surgery distribution profile in the two groups studied.
Outcome measures
| Measure |
Upper Body Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Type of Surgery ( LEA and EVAR )
EVAR
|
13 Participants
|
12 Participants
|
|
Type of Surgery ( LEA and EVAR )
LEA
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Across duration of surgery ( in minutes)Population: Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes)
The investigators will observe the duration of surgery (in minutes) in the two groups studied.
Outcome measures
| Measure |
Upper Body Blanket
n=25 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=23 Participants
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Duration of Surgery ( in Minutes)
|
180 minutes
Interval 150.0 to 210.0
|
210 minutes
Interval 135.0 to 232.5
|
Adverse Events
Upper Body Blanket
Underbody Blanket
Serious adverse events
| Measure |
Upper Body Blanket
n=25 participants at risk
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=25 participants at risk
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Immune system disorders
Anaphylatic reaction
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Upper Body Blanket
n=25 participants at risk
Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M
|
Underbody Blanket
n=25 participants at risk
Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M
|
|---|---|---|
|
Immune system disorders
Anaphylatic reaction
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Additional Information
Dr. Nelson Wolosker
Hospital Israelita Albert Einstein
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place