Heat Transfer by Clinical Warming DevicesNCT06198959
Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices
A study testing Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system. and Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 in people with Heat Transfer by Clinical Warming Devices, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators propose a single-center multiple crossover randomized trial to determine the efficacy of four warming devices and five warming blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heat Transfer by Clinical Warming Devices
- What is being tested?
- Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system. and Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body-mass index 20-33 kg/m2
- Age 18-40 yrs.
- ASA Physical Status 1-2.
Who cannot join
- Serious skin lesions
- History of allergy or skin sensitivity to tape or adhesive materials
- History of serious vascular disease in the arms, including Raynaud's Syndrome
- History of recent fever or infection
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a single-center multiple crossover randomized trial to determine the efficacy of four warming devices and five warming blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.
Read the detailed description
The investigators propose a single-center, assessor-Blinded, multiple crossover randomized trial to determine the efficacy of four warming devices and five blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.
American Society of Anesthesiologists (ASA) physical status 1 and 2 adults with body-mass index 20-33 kg/m2 will be included in this study. Volunteers will be excluded if they have serious skin lesions, history of allergy or skin sensitivity to tape or adhesive materials, serious vascular disease in the arms including Raynaud's Syndrome, or a history of recent fever or infection.
20 volunteers will be randomized to one of 5 different sequence groups: 1. Mistral Air, Blower MA1200-PM. plus the Adult Blanket plus, MA2220, 2. Mistral Air, Blower MA1200-PM plus the Premium Adult Blanket, 3320, 3. 3M, Bair Hugger, Blower 775 plus Blanket full body, 30000, 4. Smiths Medical, Blower L1-CW-100V, plus Blanket full body SWU-2001, 5. Care Essential, Cocoon, Blower CWS5000 plus Blanket Full Body blanket (CLM0101).
- Being tested
- Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.Device
Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the Adult Blanket plus, MA2220 blanket connected to the Mistral Air, Blower. MA1200-PM system for 30 minutes.
Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.Device
Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.
Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775Device
Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 system.
FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.Device
Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemDevice
Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system.
| Study group | Role | What they receive |
|---|---|---|
| ABCDE | Experimental | A. Volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. B. After a 40 minutes washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. Finally and after a last 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. Receives: Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775; Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.; Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system |
| BDECA | Experimental | B. Volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. C. After a 40-minute washout period, the volunteer will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. Finally and after a last 40-minute washout period, the volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. Receives: Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775; Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.; Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system |
| CEBAD | Experimental | C. Volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. After a 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. Finally and after a last 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. Receives: Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775; Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.; Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system |
| DCAEB | Experimental | D. Volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. Receives: Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775; Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.; Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system |
| EADBC | Experimental | E. Volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. Finally and after a last 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. Receives: Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.; Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775; Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.; Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat transfer, thermal flux
While using one of the 5 different warming blanket and warming blower systems, heat transfer will be measured on at 15 sites: Head, upper arm, forearm, hand, finger, back, chest, abdomen, medial thigh, lateral thigh, posterior thigh, anterior calve, posterior calves, foot and toe.
Measured: 30 minutes
Secondary outcomes (1)
Thermal comfort
After completing 30 minutes using the warming system, before removing the warming blanket, volunteers will rate their thermal comfort in a 0-100 mm scale. the minimum is 0 representing the coldest and the maximum value is 100 mm representing the hotest sensation the participant can report.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Feb 2024
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Transfer by Clinical Warming DevicesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators propose a single-center multiple crossover randomized trial to determine cutaneous heat transfer with four warming devices and five blankets. Cutaneous heat loss/ gain will be measured with thermal flux transducers in unanesthetized volunteers.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Surgical Company
- Responsible party
- Sponsor
- Investigators
- sessled@ccf.org Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198959
- Sponsor's protocol ID
- 22-871
- Status last verified
- Jul 2025
- First submitted
- 28 Dec 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices
- ClinicalTrials.gov ID
- NCT06198959
- Acronym / sponsor ID
- 22-871
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- The Surgical Company
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a single-center multiple crossover randomized trial to determine the efficacy of four warming devices and five warming blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.
Detailed description
The investigators propose a single-center, assessor-Blinded, multiple crossover randomized trial to determine the efficacy of four warming devices and five blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.
American Society of Anesthesiologists (ASA) physical status 1 and 2 adults with body-mass index 20-33 kg/m2 will be included in this study. Volunteers will be excluded if they have serious skin lesions, history of allergy or skin sensitivity to tape or adhesive materials, serious vascular disease in the arms including Raynaud's Syndrome, or a history of recent fever or infection.
20 volunteers will be randomized to one of 5 different sequence groups: 1. Mistral Air, Blower MA1200-PM. plus the Adult Blanket plus, MA2220, 2. Mistral Air, Blower MA1200-PM plus the Premium Adult Blanket, 3320, 3. 3M, Bair Hugger, Blower 775 plus Blanket full body, 30000, 4. Smiths Medical, Blower L1-CW-100V, plus Blanket full body SWU-2001, 5. Care Essential, Cocoon, Blower CWS5000 plus Blanket Full Body blanket (CLM0101).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The investigators propose a single-center multiple crossover randomized trial to determine cutaneous heat transfer with four warming devices and five blankets. Cutaneous heat loss/ gain will be measured with thermal flux transducers in unanesthetized volunteers.
| Arm | Type | Receives |
|---|---|---|
| ABCDE | Experimental | Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemA. Volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. B. After a 40 minutes washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. Finally and after a last 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. |
| BDECA | Experimental | Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemB. Volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. C. After a 40-minute washout period, the volunteer will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. Finally and after a last 40-minute washout period, the volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. |
| CEBAD | Experimental | Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemC. Volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. After a 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. Finally and after a last 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. |
| DCAEB | Experimental | Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemD. Volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. |
| EADBC | Experimental | Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system., Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775, Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system., Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemE. Volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. Finally and after a last 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body-mass index 20-33 kg/m2
- Age 18-40 yrs.
- ASA Physical Status 1-2.
Key exclusion criteria (4 listed)
- Serious skin lesions
- History of allergy or skin sensitivity to tape or adhesive materials
- History of serious vascular disease in the arms, including Raynaud's Syndrome
- History of recent fever or infection
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 |
|---|---|---|
| Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the Adult Blanket plus, MA2220 blanket connected to the Mistral Air, Blower. MA1200-PM system for 30 minutes. | Device | ABCDE, BDECA, CEBAD, DCAEB, EADBC |
| Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system. | Device | ABCDE, BDECA, CEBAD, DCAEB, EADBC |
| Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 system. | Device | ABCDE, BDECA, CEBAD, DCAEB, EADBC |
| FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.Evaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system. | Device | ABCDE, BDECA, CEBAD, DCAEB, EADBC |
| Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 systemEvaluate cutaneous heat loss/ gain using thermal flux transducers while volunteers are covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system. | Device | ABCDE, BDECA, CEBAD, DCAEB, EADBC |
Primary outcome
Heat transfer, thermal flux
Time frame: 30 minutes
While using one of the 5 different warming blanket and warming blower systems, heat transfer will be measured on at 15 sites: Head, upper arm, forearm, hand, finger, back, chest, abdomen, medial thigh, lateral thigh, posterior thigh, anterior calve, posterior calves, foot and toe.
1 secondary outcome
Thermal comfort
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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.
sessled@ccf.org 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 Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system., Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system. and Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 in people with Heat Transfer by Clinical Warming Devices, 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 5 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heat transfer, thermal flux (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.