Body Temperature ChangesNCT04511208
Cooling Vest May Reduce Heat Stress During Surgery
A study testing Cooling Vest and Without cooling vest in people with Body Temperature Changes, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- Cooling Vest and Without cooling vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cooling Vest May Reduce Heat Stress, Improve Thermal Comfort, and Preserve Cognitive Performance of Surgeons While Performing Surgery
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
Read the 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.
- Conditions
- Body Temperature Changes
- Being tested
- Cooling Vest, Without cooling vest
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling VestDevice
Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.
Without cooling vestDevice
Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
| Study group | Role | What they receive |
|---|---|---|
| Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA) | Experimental | 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. Receives: Device: Cooling Vest; Device: Without cooling vest |
| Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB) | Experimental | 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. Receives: Device: Cooling Vest; Device: Without cooling vest |
| Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB) | Experimental | 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. Receives: Device: Cooling Vest; Device: Without cooling vest |
| Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA) | Experimental | 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. Receives: Device: Cooling Vest; Device: Without cooling vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery, within 10 minutes
Secondary outcomes (6)
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.
Measured: the sensor will be worn for a total of 90 minutes
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.
Measured: the sensor will be worn for a total of 90 minutes
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.
Measured: Immediately after surgery, within 10 minutes
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).
Measured: Immediately after surgery, within 10 minutes
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.
Measured: Immediately after surgery, within 10 minutes
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."
Measured: Immediately after surgery, within 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start25 Aug 2020
- Primary completion9 Dec 2020
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511208
- Sponsor's protocol ID
- 20-214
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2020
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will share data on a collaborative basis.
Publications
Byrne JE, Rodriguez-Patarroyo FA, Mascha EJ, Han Y, Bravo M, Bloomfield MR, Rao SM, Sessler DI. Cooling vest improves surgeons' thermal comfort without affecting cognitive performance: a randomised cross-over trial. Occup Environ Med. 2023 Jun;80(6):339-345. doi: 10.1136/oemed-2022-108457. Epub 2023 May 4.
PubMed 37142418
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooling Vest May Reduce Heat Stress, Improve Thermal Comfort, and Preserve Cognitive Performance of Surgeons While Performing Surgery
- ClinicalTrials.gov ID
- NCT04511208
- Acronym / sponsor ID
- 20-214
- Conditions
- Body Temperature Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 28 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA) | Experimental | Device: Cooling Vest, Device: Without cooling vestSurgeons 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) | Experimental | Device: Cooling Vest, Device: Without cooling vestSurgeons 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) | Experimental | Device: Cooling Vest, Device: Without cooling vestSurgeons 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) | Experimental | Device: Cooling Vest, Device: Without cooling vestSurgeons 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling VestEvaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance. | Device | Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB), Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA), Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB), Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA) |
| Without cooling vestEvaluate surgeons' mean-body temperature and cognitive performance without cooling vest. | Device | Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB), Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA), Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB), Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA) |
Primary outcome
Self-rated Thermal Comfort.
Time frame: 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.
6 secondary outcomes
Mean Core Temperature.
Time frame: the sensor will be worn for a total of 90 minutes
Mean Skin Temperature
Time frame: the sensor will be worn for a total of 90 minutes
Surgeons' Cognitive Performance, Measured With the C3B Battery.
Time frame: Immediately after surgery, within 10 minutes
Surgeon' Perceived Ergonomic Workload Measured With the Borg Rating of Perceived Exertion (RPE) Scale.
Time frame: Immediately after surgery, within 10 minutes
Surgeon' Perceived Fatigue Measured as 0 Representing Not Fatigued at All, 5 Moderately Fatigued, and 10 Total Fatigue & Exhaustion
Time frame: Immediately after surgery, within 10 minutes
Surgeons' Perception and Amount of Sweat-soaked Scrub Clothing.
Time frame: Immediately after surgery, within 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142418Byrne JE, Rodriguez-Patarroyo FA, Mascha EJ, Han Y, Bravo M, Bloomfield MR, Rao SM, Sessler DI. Cooling vest improves surgeons' thermal comfort without affecting cognitive performance: a randomised cross-over trial. Occup Environ Med. 2023 Jun;80(6):339-345. doi: 10.1136/oemed-2022-108457. Epub 2023 May 4.
- Individual participant dataSharing planned: Yes. We will share data on a collaborative basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Vest and Without cooling vest in people with Body Temperature Changes, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated Thermal Comfort. (time frame: Immediately after surgery, within 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.