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临床试验/NCT06145113
NCT06145113尚未招募不适用

The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
Lake Louise score for symptoms of acute mountain sickness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Each participant will not be aware of which arm to which they have been assigned. The on-site investigator will be responsible for randomization, so they will not be able to be blinded.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • present in Pheriche, Nepal;
  • Lake Louise score > 1 (with or without formal AMS diagnosis)

排除标准

  • 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

结局指标

主要结局

Lake Louise score for symptoms of acute mountain sickness

时间窗: Prior to intervention, immediately following intervention, morning following intervention

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

次要结局

  • Pulse oximetry(Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention)
  • Heart rate(Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention)
  • Respiratory rate(Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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