Acute Mountain Sickness Clinical Trial
Official title:
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
Acute Mountain Sickness (AMS) is a common condition affecting individuals traveling to elevations greater than 2500 meters (8200 feet). While more gradual ascent profiles, as well as the use of acetazolamide, have been shown to decrease the incidence of AMS, it remains a common condition that can affect anyone who travels to altitude. Many pharmacologic options for treatment of AMS exist, however these are not always effective or able to be taken by all patients. Continuous positive airway pressure (CPAP) has been shown in some small studies and reports to be a potential non-pharmacologic method of both preventing and treating AMS. No large trials to validate the efficacy of CPAP in altitude related illness have been done. This study aims to evaluate the degree to which CPAP can improve symptoms of AMS, as well as improve oxygen saturation among individuals traveling in a high altitude location.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | August 10, 2024 |
Est. primary completion date | June 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - present in Pheriche, Nepal; - Lake Louise score > 1 (with or without formal AMS diagnosis) Exclusion Criteria: - History of chronic respiratory conditions (uncontrolled asthma, COPD, ILD) - obstructive sleep apnea (if currently using nighttime CPAP) - congestive heart failure - coronary artery disease - history of myocardial infarction - neurologic disorder - cognitive disorder - altered mental status - pregnancy - current use of supplemental oxygen - excessive facial hair, - claustrophobia |
Country | Name | City | State |
---|---|---|---|
Nepal | Himalayan Rescue Association | Pheriche |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Himalayan Rescue Association |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lake Louise score for symptoms of acute mountain sickness | This is a validated set of criteria used for research purposes to quantify symptoms of acute mountain sickness.
A Lake Louise score greater than or equal to 3 is considered diagnostic of acute mountain sickness, and ranges from 0 to 15. Higher Lake Louise scores are associated with more severe symptoms and level of disability. The criteria are as follows: Headache: 0-3 Gastrointestinal symptoms: 0-3 Fatigue and/or weakness: 0-3 Dizziness/light-headedness: 0-3 AMS Clinical Functional Score: 0-3 |
Prior to intervention, immediately following intervention, morning following intervention | |
Secondary | Pulse oximetry | Level of peripheral oxygen saturation as measured by pulse oximeter (0-100%) | Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention | |
Secondary | Heart rate | Measured by palpation of peripheral pulses or pulse oximeter (beats per minute) | Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention | |
Secondary | Respiratory rate | Measured by observation of chest rise and fall (breaths per minute) | Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention |
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