Evidence map›Paper›PMID 39891247›Full record

Trial reportScandinavian journal of trauma, resuscitation and emergency medicine2025

Experimental hypothermia by cold air: a randomized, double-blind, placebo-controlled crossover trial.

Ane M Helland, Sigurd Mydske, Jörg Assmus, Guttorm Brattebø, Øystein Wiggen, Haakon K Kvidaland, Øyvind Thomassen

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Scandinavian journal of trauma, resuscitation and emergency medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ane M HellandDepartment of Clinical Medicine, University of Bergen, Storgata 33A, 0103, Bergen, Oslo, Norway. Ane.marthe.helland@norskluftambulanse.no.
Sigurd MydskeDepartment of Clinical Medicine, University of Bergen, Storgata 33A, 0103, Bergen, Oslo, Norway.
Jörg AssmusMountain Medicine Research Group, The Norwegian Air Ambulance Foundation, Bergen, Norway.
Guttorm BrattebøDepartment of Clinical Medicine, University of Bergen, Storgata 33A, 0103, Bergen, Oslo, Norway.
Øystein WiggenMountain Medicine Research Group, The Norwegian Air Ambulance Foundation, Bergen, Norway.
Haakon K KvidalandDepartment of Pediatrics, Haukeland University Hospital, Bergen, Norway.
Øyvind ThomassenDepartment of Clinical Medicine, University of Bergen, Storgata 33A, 0103, Bergen, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccidental hypothermia is associated with high morbidity and mortality. Research on treatment strategies for accidental hypothermia is complicated by the low incidence and heterogeneous patient population. We have developed a new method for clinical trials of experimental hypothermia, to enable further studies of active rewarming. If cold ambient air is effective as a cooling method, this would mimic the most frequent clinical setting of hypothermic patients and provide a feasible cooling method for field studies. We aimed to induce mild hypothermia in healthy volunteers by exposure to cold ambient air, and tested the hypothesis that drug-induced suppression of endogenous thermoregulation would be required.

methodsIn a randomized, double-blind, crossover design, 15 healthy volunteers wearing wet clothes were put in a windy climate chamber set to 5 °C. Each participant completed the experimental procedure twice, once receiving active drugs (meperidine and buspirone) and once receiving placebo. The experiments were separated by a one-week wash-out period. Primary outcome was core temperature at termination, defined as 3 h of exposure or 35 °C. The between-groups difference was assessed using analysis of covariance (ANCOVA) with left censoring (Tobit model) and individual random intercept. Secondary outcomes were trajectory of core temperature and reduction of shivering.

resultsAt termination, the active drug vs placebo group differed in temperature by 1.4 °C. With adjustment for the removal of participants reaching 35 °C, the estimated mean difference was 1.7 °C (1.4-2.0, p < 0.001). Shivering was effectively reduced, but not completely inhibited by the drug regimen, and core temperature declined at a rate of - 0.82 °C per hour.

conclusionThe novel protocol utilizing cold air as a cooling method and drug-induced suppression of endogenous thermoregulation, is effective and enables future research projects. We have provided suggestions for minor alterations.

trial registrationEudraCT ID 2023-506020-81-00.

Indexed as

Body Temperature RegulationCold TemperatureHypothermiaHypothermia, InducedAdultCross-Over StudiesDouble-Blind MethodFemaleHealthy VolunteersHumansMaleShiveringYoung AdultAccidental hypothermiaEmergency medicineMountain medicinePrehospitalProtocolShiveringThermoregulation

Identifiers

PMID39891247
PMCPMC11786356

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.