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Cooling Vest May Reduce Heat Stress During Surgery
NA trial testing Cooling Vest in Body Temperature Changes in 30 participants. Completed in 25 February 2022.
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 25 August 2020 |
| Primary completion | 9 December 2020 |
| Estimated completion | 25 February 2022 |
| Sites | 1 location across United States |
The Cleveland Clinic
Adults 25 to 65, any sex, with Body Temperature Changes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 4.4 | ± 0.19 |
| Without Cooling Vest | 6.6 | ± 0.19 |
The 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.
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 32.9 | ± 0.09 |
| Without Cooling Vest | 33.2 | ± 0.09 |
The 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
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 36.1 | ± 0.13 |
| Without Cooling Vest | 36.3 | ± 0.13 |
Surgeons' 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.
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 69.4 | ± 0.82 |
| Without Cooling Vest | 69.4 | ± 0.82 |
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 58.3 | ± 1.42 |
| Without Cooling Vest | 57.7 | ± 1.41 |
Immediately 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).
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 13 | 11 – 13 |
| Without Cooling Vest | 13 | 12 – 15 |
Perceived 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.
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 2.3 | ± 0.26 |
| Without Cooling Vest | 3.3 | ± 0.25 |
Immediately 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."
| Group | Value | 95% CI |
|---|---|---|
| Cooling Vest | 1.4 | ± 0.38 |
| Without Cooling Vest | 4.4 | ± 0.38 |
The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon. Surgeons will be randomized to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in that each treatment appears the same number of times within each sequence (uniform within sequence) and if each treatment appears the same number of times within each period (uniform within each period). It is strongly balanced with respect to first-order carryover effects because each treatment precedes every other treatment, including itself, the same number of times
1 peer-reviewed publication reference this trial (live from Europe PMC):
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