Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145113
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-14
Brief Title:
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None