The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care

NCT06446427 | Completed DMC

• 1 other identifier: 2024-00237
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Rescue services in mountainous regions are frequently called to missions at altitudes \>3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures. Previous studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have found that the lack of oxygen associated with acute exposure to altitude may impair cognitive functions. No data exists on the effect this may have on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The investigators of this study aim to make rescue missions to high altitude safer for both the patients and the rescuers. To assess the effect of high altitude on patient care, the investigators recruit highly trained medical specialists who will perform patient care in simulated scenarios both at high altitude and at low altitude. These scenarios will be recorded and the performance of the medical specialists judged by independent reviewers. The medical specialists will also perform in simulated scenarios at high altitude two more times: once with supplementary oxygen, and once after spending a night at high altitude. the investigators do this to evaluate whether supplementary oxygen improves their performance, and whether symptoms of acute mountain sickness (which usually develop after spending the first night at high altitude) decreases their performance further.

Conditions

Hypobaric Hypoxia; Risk Reduction; High Altitude

Keywords

High Altitude; Hypobaric Hypoxia; Patient Care; Patient Safety; Rescuer Safety; Emergency Medicine; Anaesthesia

Outcome Measures

Primary Outcomes (3)

• The effect of acute high altitude exposure on medical performance, measured by the STAT score

  The investigators asses the quality of patient care at low and high altitude exposure. The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure. The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.

  Baseline, intervention 1 (30 minutes after arriving at high altitude)

• The effect of acute high altitude exposure on medical performance, measured by the CALM score

  The investigators asses the quality of patient care at low and high altitude exposure. The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure. The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.

  Baseline, intervention 1 (30 minutes after arriving at high altitude)

• The effect of acute high altitude exposure on medical performance, measured by the TEAM score

  The investigators asses the quality of patient care at low and high altitude exposure. The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure. The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.

  Baseline, intervention 1 (30 minutes after arriving at high altitude)

Secondary Outcomes (5)

• The effect of supplementary oxygen on medical performance during acute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores

  Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen)

• The effect of subacute high altitude exposure on medical performance, measured as a composite of STAT, CALM, and TEAM scores

  Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 3 (after having spent a night at high altitude)

• The effect of gender and age on medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores

  Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)

• The correlations between psychomotor test results (PVT, BART, DSST, self-assessment of cognitive function) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores

  Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)

• The correlations between vital parameters (blood pressure, heart rate, peripheral blood oxygen saturation) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores

  Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)

Interventions

Acute high altitude exposure OTHER

Thirty minutes after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 1", high altitude at 3450 masl) is performed.

Also known as: Intervention 1

Acute high altitude exposure, with supplementary oxygen OTHER

4 hours after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 2", high altitude at 3450 masl) is performed, while the participants receive 4 litres / minute of oxygen via nasal route.

Also known as: Intervention 2

Subacute high altitude exposure, after having spent a night at high altitude OTHER

After having spent a night at the Research Station Jungfraujoch, a simulated scenario of patient care ("Intervention 3", high altitude at 3450 masl) is performed.

Also known as: Intervention 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical doctors with certification and experience in preclinical emergency medicine, defined as (all must apply):
• or more years of training in anaesthesiology
• or more months of preclinical work
• or more cases as the lead preclinical physician with potential danger to the patient's life (with a National Advisory Committee for Aeronautics score (NACA) of 4 or more)
• A valid preclinical certification (Swiss "Notarztkurs" or similar)
• Written informed consent to participate in the study

You may not qualify if:

• Any medical condition known to place the participant at higher risk for hypoxia-induced adverse events (cardiovascular, pulmonary, neurological, otherwise).
• Pre-acclimatisation to high altitude, defined as travel to above 2500 m in the 4 weeks previous to the study

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Berner Simulations- und CPR-Zentrum BeSiC

Bern, 3010, Switzerland

Location

High Altitude Research Station Jungfraujoch

Bern, 3012, Switzerland

Location

Related Publications (36)

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MeSH Terms

Conditions

Altitude Sickness; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Behavior

Study Officials

• Juergen Knapp, PD, MD

  University Hospital of Bern (Inselspital), Department of Anaesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants cannot be masked to whether they are at high or low altitude and whether they have spent a night at high altitude. However, they will not know whether they receive air (baseline, interventions 1 and 3) or supplementary oxygen nasally at the same flow rate (intervention 2). Outcome Assessors will be fully blinded. They assess the medical performance on video recordings of the simulated scenarios, and will not know which time point a specific scenario has taken place (baseline, interventions 1-3) and whether participants receive air or supplementary oxygen.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators imply a repeated measures design. A group of 20 participants will perform in simulated medical scenarios sequentially under four different circumstances (baseline, interventions 1-3)

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 6, 2024
• Study Start: August 2, 2024
• Primary Completion: February 9, 2025
• Study Completion: July 3, 2025
• Last Updated: April 29, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)