Clinical trial NCT06145113: The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
Official title: The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Mountain Sickness
Keywords: Acute mountain sickness
Altitude
CPAP
Positive airway pressure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Himalayan Rescue Association
First posted: 2023-11-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: AMS is commonly experienced among travelers in all high altitude locations, and can affect anyone who travels to one of these places. This illness can be prevented, and after its symptoms have been started, can be treated with medication, as well as by descending to a lower elevation. The medications for AMS symptoms, including acetazolamide, dexamethasone, and ibuprofen are not always effective, and even when they are, often take considerable time to show their effect. Additionally, not all patients can take these medications. When these medications are not effective, or there is a contraindication to their use, descent to a lower elevation is necessary, however this is not always possible due to weather, debilitating symptoms, or coinciding diagnoses of high altitude pulmonary edema (HAPE) or high altitude cerebral edema (HACE). These situations require a difficult and complicated evacuation, requiring multiple rescuers and heavy equipment, or increased risk of clinical deterioration.

CPAP has been shown to be a potential non-pharmacologic method of both preventing and treating AMS. These limited studies quantified symptoms using the Lake Louise score {LLS}, a clinical tool used to assess the severity of AMS. They showed that LLS among subjects receiving CPAP, LLS lower when using it prophylactically or after AMS symptoms had started, however these were not compared against placebo. Additionally, over the last five years, CPAP devices have become quite portable and battery powered, making them much more suitable for travel to wilderness and high altitude locations. They are also available to consumers at low cost, are designed for travel and weigh less than 1 kg. Taking advantage of these devices' portability, a potential new treatment modality for AMS and other altitude related illnesses exists. Additionally, these devices can offer new solutions for mountain rescue and evacuation of patients suffering from altitude related illness, as these devices have been shown in a yet-to-be-published study to improve oxygen saturation and work of breathing while ambulating and self-carrying the device. Improvements in these assessments has been rapid (less than 2 minutes), potentially offering a more rapid treatment of AMS than existing pharmacologic agents as well. This study will be done in Pheriche, Nepal, as it is a location that has a uniquely elevated prevalence of altitude-related illness.

Eligibility criteria: 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

Primary outcomes:
measure: Lake Louise score for symptoms of acute mountain sickness
timeFrame: Prior to intervention, immediately following intervention, morning following intervention
Secondary outcomes:
measure: Pulse oximetry
timeFrame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
measure: Heart rate
timeFrame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
measure: Respiratory rate
timeFrame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Other outcomes:
Locations:
city: Pheriche
country: Nepal
facility: Himalayan Rescue Association
Study officials:
References: