Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness

BiALP - Alpine, Disaster and Wilderness Medicine

Status: Not yet enrolling

Conditions: Acute Mountain Sickness (AMS)

Treatments: Device: Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT07148674

6962

Details and patient eligibility

About

This pilot study aims to evaluate the efficacy of positive expiratory pressure (PEP) therapy at 10 cmH₂O in improving peripheral oxygen saturation (SpO₂) and mitigating symptoms of acute mountain sickness (AMS) in healthy individuals exposed to extreme altitude conditions.

Three male participants will be monitored during an ascent of Mount Aconcagua, Argentina, at elevations of 4,300 m, 5,560 m, and 6,000 m above sea level. The study involves three sequential phases of 10 minutes each: baseline breathing without PEP, breathing with PEP applied via a mechanical face mask, and post-PEP breathing.

Primary outcomes include changes in SpO₂ and Lake Louise Score (LLS) to assess AMS severity. Findings will provide preliminary data on the potential role of PEP as a non-pharmacological intervention in high-altitude medicine.

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers without ongoing medical conditions
• Over 18 years of age
• Volunteers with the physical and technical skills necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina, and with previous experience at extreme altitudes

Exclusion criteria

• Subjects with any ongoing medical conditions
• Under 18 years of age
• Subjects without previous mountaineering experience at extreme altitudes and without adequate physical and technical preparation necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Intervention

Experimental group

Description:

Pilot trial of positive expiratory pressure for acute mountain sickness. 1 single arm with 3 phases: * 1: Baseline Breathing (No PEP) Participants breathe normally without any device for 10 minutes in supine position, serving as control. * 2: Positive Expiratory Pressure (PEP) Breathing Participants breathe through a face mask with a mechanical PEP device set at 10 cmH₂O expiratory pressure for 10 minutes supine. Inspiration is unrestricted; expiration occurs against resistance to improve oxygenation and reduce AMS symptoms. * 3: Post-PEP Breathing (No PEP) After PEP, participants breathe normally for 10 minutes supine. Each phase is consecutive at altitudes 4,300 m, 5,560 m, and 6,000 m

Treatment:

Device: Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia