Heat Transfer by Clinical Warming Devices
Conditions
Brief 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.
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).
Interventions
DEVICEAdult 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.
DEVICEPremium 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.
DEVICEBlanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
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.
DEVICEFilteredFlo® 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.
DEVICEBlanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.
Sponsors
The Cleveland Clinic
The Surgical Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body-mass index 20-33 kg/m2 * Age 18-40 yrs. * ASA Physical Status 1-2.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heat transfer, thermal flux | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thermal comfort | 30 minutes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORsessled@ccf.org Sessler, MD
The Cleveland Clinic
Outcome results
None listed