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OpenTrials
Completed

NCT Number: NCT06198959

Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices

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.

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Key information

Conditions

Heat Transfer by Clinical Warming Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 775

Device

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 system

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Thermal comfort

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • The Surgical Company

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.