Trial Outcomes & Findings for Cooling Vest May Reduce Heat Stress During Surgery (NCT NCT04511208)
NCT ID: NCT04511208
Last Updated: 2022-07-28
Results Overview
Immediately after surgery, while still gowned, surgeons will rate their thermal comfort on a 0-10 Likert scale, with 0 representing extreme cold, 5 being thermal comfort, and 10 representing extreme heat. Two points on the 11-point Likert scale will be considered a clinically important difference.
COMPLETED
NA
30 participants
Immediately after surgery, within 10 minutes
2022-07-28
Participant Flow
Participant milestones
| Measure |
Cooling Vest, Then Without Cooling Vest, Then Without Cooling Vest, Then Cooling Vest (ABBA)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed one surgery without the cooling vest. Then on another day, they performed another surgery without the cooling vest. Then they finally performed one surgery with the cooling vest.
|
Without Cooling Vest, Then Cooling Vest, Then Cooling Vest, Then Without Cooling Vest (BAAB)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed one surgery with the cooling vest. Then on another day, they performed another surgery with the cooling vest. Then they finally performed one surgery without the cooling vest.
|
Cooling Vest, Then Cooling Vest, Then Without Cooling Vest, Then Without Cooling Vest (AABB)
Surgeons first performed one surgery with the cooling vest. On another day, they then performed another surgery with the cooling vest. Then on another day, they performed one surgery without the cooling vest. Then they finally performed another surgery without the cooling vest.
|
Without Cooling Vest, Then Without Cooling Vest, Then Cooling Vest, Then Cooling Vest (BBAA)
Surgeons first performed one surgery without the cooling vest. On another day, they then performed another surgery without the cooling vest. Then on another day, they performed one surgery with the cooling vest. Then they finally performed another surgery with the cooling vest.
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|---|---|---|---|---|
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First Surgery
STARTED
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8
|
7
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8
|
7
|
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First Surgery
COMPLETED
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8
|
7
|
8
|
7
|
|
First Surgery
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Surgery
STARTED
|
8
|
7
|
8
|
7
|
|
Second Surgery
COMPLETED
|
8
|
7
|
8
|
7
|
|
Second Surgery
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Surgery
STARTED
|
8
|
7
|
8
|
7
|
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Third Surgery
COMPLETED
|
8
|
7
|
8
|
7
|
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Third Surgery
NOT COMPLETED
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0
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0
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0
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0
|
|
Forth Surgery
STARTED
|
8
|
7
|
8
|
7
|
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Forth Surgery
COMPLETED
|
8
|
7
|
8
|
7
|
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Forth Surgery
NOT COMPLETED
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0
|
0
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0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cooling Vest May Reduce Heat Stress During Surgery
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
All participants were randomized to receive all interventions
|
|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26 kg/m^2
n=5 Participants
|
|
Height
|
181 cm
n=5 Participants
|
|
Weight
|
85 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after surgery, within 10 minutesImmediately after surgery, while still gowned, surgeons will rate their thermal comfort on a 0-10 Likert scale, with 0 representing extreme cold, 5 being thermal comfort, and 10 representing extreme heat. Two points on the 11-point Likert scale will be considered a clinically important difference.
Outcome measures
| Measure |
Cooling Vest
n=30 Participants
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=30 Participants
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Self-rated Thermal Comfort.
|
4.4 score on a scale
Standard Error 0.19
|
6.6 score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: the sensor will be worn for a total of 90 minutesThe first secondary outcome will be the mean core temperature for a case, calculated as the time-weighted average over the taken measurements. The surgeon's core body temperature will be monitored by a validated wireless wearable iThermonitor WT701 biosensor which estimates core temperature within ±0.5⁰C (Pei et al., 2018). The sensor will be applied to the surgeon's right axilla 15-20 minutes prior to the surgical hand scrub performed at the start of surgery and secured with an adhesive cover. A small patch of axillary hair will be clipped or shaved as necessary.
Outcome measures
| Measure |
Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Mean Core Temperature.
|
32.9 ℃
Standard Error 0.09
|
33.2 ℃
Standard Error 0.09
|
SECONDARY outcome
Timeframe: the sensor will be worn for a total of 90 minutesThe second secondary outcome will be the mean skin temperature for a case, calculated as the time-weighted average over the taken measurements. Mean skin temperature will be estimated from skin temperature from the back of the upper chest, deltoid arm, thigh, and calf using the formula \[MSTR = 0.3 chest + 0.3 arm + 0.2 thigh + 0.2 leg or 0.3(chest + arm) + 0.2(thigh + 0.2 leg)\] (Ramanathan, 1964). Skin temperature will be continuously measured using wireless patches, TempTraq, which meet professional accuracy standards for digital thermometers (ASTM E1112-00). The sensors will remain affixed with adhesive dressing on the surgeon's body surface throughout surgery and approximately 10 minutes required for post-operative testing.
Outcome measures
| Measure |
Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Mean Skin Temperature
|
36.1 ℃
Standard Error 0.13
|
36.3 ℃
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Immediately after surgery, within 10 minutesSurgeons' cognitive performance was assessed with the Cleveland Clinic Cognitive Battery (C3B, Cleveland, OH), a ten-minute-long self-administered computer tablet program that tests visual memory (episodic learning and delayed memory, range 0 - 70) and processing speed (information processing speed and incidental memory, range 40 - 120). Testing will take place right after surgery with surgeons still gowned. The surgeons will sit with the iPad touch screen placed on a desk in front of them for approximately 10 minutes to complete the cognitive test.
Outcome measures
| Measure |
Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Surgeons' Cognitive Performance, Measured With the C3B Battery.
C3B Processing Speed Test Score
|
69.4 score on a scale
Standard Error 0.82
|
69.4 score on a scale
Standard Error 0.82
|
|
Surgeons' Cognitive Performance, Measured With the C3B Battery.
C3B Visual Memory Test Score
|
58.3 score on a scale
Standard Error 1.42
|
57.7 score on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: Immediately after surgery, within 10 minutesImmediately after surgery, while still gowned, surgeons will rate their perceived exertion on the Borg scale which ranges from 6 (no exertion) to 20 (maximal exertion).
Outcome measures
| Measure |
Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale.
|
13 score on a scale
Interval 11.0 to 13.0
|
13 score on a scale
Interval 12.0 to 15.0
|
SECONDARY outcome
Timeframe: Immediately after surgery, within 10 minutesPerceived fatigue will be rated on a 0-10 ROF scale, with 0 representing not fatigued at all, 5 moderately fatigued, and 10 total fatigue \& exhaustion. Two points difference on either scale will be considered a clinically important difference.
Outcome measures
| Measure |
Cooling Vest
n=30 Participants
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=30 Participants
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion
|
2.3 score on a scale
Standard Error 0.26
|
3.3 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Immediately after surgery, within 10 minutesImmediately after surgery, while still gowned, surgeons' perception and amount of sweat-soaked scrub clothing will be rated using a Likert scale from 0 = "not wet at all" to 10 = "fully drenched."
Outcome measures
| Measure |
Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort using the cooling Ice vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
|
Without Cooling Vest
n=60 Surgeries
Evaluate surgeons' self-rated thermal comfort without using the Cooling Ice Vest during prolonged and strenuous surgery
Cooling Vest: Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Control Group without cooling vest: Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
|
|---|---|---|
|
Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing.
|
1.4 score on a scale
Standard Error 0.38
|
4.4 score on a scale
Standard Error 0.38
|
Adverse Events
Cooling Ice Vest
Without Cooling Ice Vest
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place