The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia

NCT06342726 | Completed

• 1 other identifier: 2024/714469
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature. The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine.

Conditions

Accidental Hypothermia

Outcome Measures

Primary Outcomes (1)

• Core body temperature

  Esophageal measurement

  2 hour cooling phase, 1 hour rewarming phase

Study Arms (2)

Passive rewarming

PLACEBO COMPARATOR

Wrapping of participants using a 3-layered model with a vapor barrier, insulating materials and an outer shell.

Device: Passive insulation

Active rewarming

ACTIVE COMPARATOR

Same as "Passive rewarming" but with an added external heat source

Device: PAX Warming Blanket; Device: Passive insulation

Interventions

PAX Warming Blanket DEVICE

Electric resistive active external warming blanket

Active rewarming

Passive insulation DEVICE

3-layered wrapping model

Active rewarming; Passive rewarming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidine, chlorpromazine, phenytoin, erythromycin, itraconazole, platelet inhibitors, Apomorphine, alcohol (during the trial period) or other opioids or opioid antagonists (during the trial period). History of drug dependency.
• Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
• Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, myasthenia gravis. Previous abdominal surgery. History of cold injuries or frostbites.
• Planned MRI the next two days after ingestion of temperature capsule.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• Mydske S, Helland AM, Borasio N, Brattebo G, Osteras O, Wiggen O, Assmus J, Strapazzon G, Thomassen O. Effect of active external rewarming on esophageal temperature in simulated prehospital accidental hypothermia: a randomized crossover trial. Scand J Trauma Resusc Emerg Med. 2025 Dec 12. doi: 10.1186/s13049-025-01528-7. Online ahead of print.

  PMID: 41388306 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent. Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized. When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: May 28, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)