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

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NeuroTherapia, Inc.

Status

Enrolling

Conditions

Heat Transfer by Clinical Warming Devices

Treatments

Device: Premium adult blanket, 3320 blanket connected to the Mistral Air, Blower MA1200-PM system.
Device: Adult blanket plus, MA2220 blanket connected to the Mistral Air, Blower MA1200-PM system.
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 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.

Study type

Interventional

Funder types

Other

Identifiers

NCT06198959
22-871

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 5 patient groups

ABCDE
Experimental group
Description:
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.
Treatment:
Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.
BDECA
Experimental group
Description:
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.
Treatment:
Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.
CEBAD
Experimental group
Description:
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.
Treatment:
Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.
DCAEB
Experimental group
Description:
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.
Treatment:
Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.
EADBC
Experimental group
Description:
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.
Treatment:
Device: FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system.
Device: Blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775
Device: Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system
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.

Trial contacts and locations

1

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Central trial contact

Daniel Sessler, MD; Fabio Rodriguez, MD

Data sourced from clinicaltrials.gov

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