Body Temperature Changes
Conditions
Brief summary
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
Detailed description
The subjects will be randomly assigned to use either the CoolSource™ cooling vest (worn between scrubs) and a conventional surgical gown for each of 4 surgeries. Sequence of treatments within the subjects will be randomized (ABBA, BAAB, AABB or BBAA), and determined using the PLAN procedure in SAS, such that each surgeon will wear vest and non-vest twice. The sequencing will not be shared with any study personnel. Allocation for each case will be concealed with a web-based system that will be accessed only shortly before surgery. The investigators will target an ambient temperature of 21°C ± 1°C, and try to maintain the same temperature of each of the four study cases for each surgeon. The CoolSource vest holds six reusable cooling packs located bilaterally on the shoulders, angled flank along the base of the rib cage, and along each side of the spine, mid-back. The vest will be donned over hospital-issued scrubs after all temperature sensing devices have been applied and before surgical hand scrubbing. The subjects will wear the vest throughout surgery, and for a few additional minutes while postoperative assessments are made (details below). The weight of the disposable cooling vest is 1 kg which is evenly distributed over both shoulders. The cooling packs have an insulated cover to reduce condensation or sweating while seated inside the vest pocket. The flexible frozen reusable cooling packs will be inserted into each of the six pockets and the vest belt will be tied to hold the cooling packs securely. The disposable cooling vests will be discarded after each case, and the cooling packs returned to a freezer.
Interventions
DEVICECooling Vest
Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
DEVICEWithout cooling vest
Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Surgeons who perform elective major orthopedic surgery such as total hip and knee arthroplasties scheduled for 90 to 150 minutes at the Cleveland Clinic Main Campus. * Orthopedic surgeons ages of 25-65 years old, as body temperatures may be lower and less stable in the elderly (Waalen & Buxbaum, 2011), who operate frequently enough to participate in four cross-over cases. * Surgical helmet system is consistently worn for each of the surgeon's four cases, if used in the first case.
Exclusion criteria
* Surgical cases that require surgeons to sit on stools during the procedure, which may impact temperature and energy expenditure. * \- Surgeons who report having a recent illness within 24 hours prior to the surgery, symptoms producing a febrile condition; * Surgeons who worked the previous evening. * Surgeons who wear lead X-ray gowns.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-rated Thermal Comfort. | Immediately after surgery, within 10 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Skin Temperature | the sensor will be worn for a total of 90 minutes | 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 with adhesive dressing on the surgeon's body surface throughout surgery and approximately 10 minutes required for post-operative testing. |
| Surgeons' Cognitive Performance, Measured With the C3B Battery. | Immediately after surgery, within 10 minutes | 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. |
| Mean Core Temperature. | the sensor will be worn for a total of 90 minutes | 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. |
| Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion | Immediately after surgery, within 10 minutes | 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. |
| Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing. | Immediately after surgery, within 10 minutes | 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. |
| Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale. | Immediately after surgery, within 10 minutes | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants were randomized to receive all interventions | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 9 |
| Body Mass Index (BMI) | 26 kg/m^2 |
| Height | 181 cm |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Black/African American | 1 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 participants |
| Race/Ethnicity, Customized White/Caucasian | 26 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
| Weight | 85 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Self-rated Thermal Comfort.
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.
Time frame: Immediately after surgery, within 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooling Vest | Self-rated Thermal Comfort. | 4.4 score on a scale | Standard Error 0.19 |
| Without Cooling Vest | Self-rated Thermal Comfort. | 6.6 score on a scale | Standard Error 0.19 |
p-value: <0.00195% CI: [-2.7, -1.7]Repeated measures linear model
Secondary
Mean Core Temperature.
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.
Time frame: the sensor will be worn for a total of 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooling Vest | Mean Core Temperature. | 32.9 ℃ | Standard Error 0.09 |
| Without Cooling Vest | Mean Core Temperature. | 33.2 ℃ | Standard Error 0.09 |
p-value: 0.00695% CI: [-0.44, -0.08]Repeated measures linear model
Secondary
Mean Skin Temperature
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 with adhesive dressing on the surgeon's body surface throughout surgery and approximately 10 minutes required for post-operative testing.
Time frame: the sensor will be worn for a total of 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooling Vest | Mean Skin Temperature | 36.1 ℃ | Standard Error 0.13 |
| Without Cooling Vest | Mean Skin Temperature | 36.3 ℃ | Standard Error 0.13 |
p-value: 0.04695% CI: [-0.45, -0.005]Repeated measures linear model
Secondary
Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale.
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).
Time frame: Immediately after surgery, within 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cooling Vest | Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale. | 13 score on a scale |
| Without Cooling Vest | Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale. | 13 score on a scale |
p-value: 0.00795% CI: [1.28, 4.68]Generalized linear mixed effects model
Comparison: Sensitivity analysisp-value: 0.00995% CI: [-1.82, -0.28]Repeated measures linear model
Secondary
Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion
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.
Time frame: Immediately after surgery, within 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 |
| Without Cooling Vest | Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion | 3.3 score on a scale | Standard Error 0.25 |
p-value: 0.00495% CI: [-1.75, -0.38]Repeated measures linear model
Secondary
Surgeons' Cognitive Performance, Measured With the C3B Battery.
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.
Time frame: Immediately after surgery, within 10 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Cooling Vest | Surgeons' Cognitive Performance, Measured With the C3B Battery. | C3B Visual Memory Test Score | 58.3 score on a scale | Standard Error 1.42 |
| 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 |
| Without Cooling Vest | Surgeons' Cognitive Performance, Measured With the C3B Battery. | C3B Visual Memory Test Score | 57.7 score on a scale | Standard Error 1.41 |
Comparison: C3B PST Scorep-value: 0.95595% CI: [-2.51, 2.38]Repeated measures linear model
Comparison: C3B VMT Scorep-value: 0.68695% CI: [-2.48, 3.71]Repeated measures linear model
Secondary
Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing.
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.
Time frame: Immediately after surgery, within 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooling Vest | Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing. | 1.4 score on a scale | Standard Error 0.38 |
| Without Cooling Vest | Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing. | 4.4 score on a scale | Standard Error 0.38 |
p-value: <0.00195% CI: [-3.8, -2.13]Repeated measures linear model