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

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.

Conditions

• Heat Transfer by Clinical Warming Devices

Interventions

DEVICE

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

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

Blanket 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.

DEVICE

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

Blanket 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 & Collaborators

• The Surgical Company

  collaborator UNKNOWN

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• [email protected] Sessler, MD · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-15

Primary Completion

2026-03-02

Completion

2026-03-02

FDA Device

Yes

Countries

• United States

Study Locations