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Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude

Primary Purpose

Hypoxemia, Altitude Hypoxia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure
Ambient air
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults (age 18-70) Living at lower elevation (<2500m or 8200ft) Exclusion Criteria: Age > 70 or age < 18. History of chronic respiratory conditions (asthma, COPD, ILD) Obstructive sleep apnea (if currently using nighttime CPAP) Congestive heart failure, coronary artery disease History of myocardial infarction History of HAPE Neurologic disorder Cognitive disorder Altered mental status Pregnancy Current use of supplemental oxygen Impaired mobility Excessive facial hair Claustrophobia. Current use of altitude-related illness prophylaxis medications Current use of anticoagulant medications Current use of calcium channel blockers medications

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Continuous Positive Airway Pressure use

Ambient air

Arm Description

Outcomes

Primary Outcome Measures

Peripheral oxygen saturation
SpO2 measurement in percentage
Respiratory rate
Breaths/minute
Heart rate
Heartbeats/minute

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 24, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05971290
Brief Title
Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude
Official Title
Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 22, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dyspnea and exercise intolerance are well known to travelers who have experienced time at high elevations, greater than 2500 meters (8200 feet). As individuals ascend to higher elevations, oxygen saturations significantly decrease as the partial pressure of oxygen decreases. Additionally, many individuals develop subclinical cases of high altitude pulmonary edema (HAPE), which may worsen hypoxemia and decrease exercise performance. While dyspnea and exercise intolerance are usually self-limiting and improve with rest, some individuals experience severe symptoms that prevent safe evacuation to lower elevation. Individuals experiencing high altitude dyspnea, subclinical HAPE, or clinical HAPE will see improvements in symptoms and SpO2 when receiving supplemental oxygen, however this requires heavy and unwieldy tanks that make it difficult to carry across irregular terrain. Additionally, given the often-remote conditions where supplemental oxygen is needed, it is often difficult to replenish supplies. Other devices, such as the portable hyperbaric chamber (often referred to as Gamow bag), can temporarily improve dyspnea and oxygen saturation at high and extreme altitudes without the use of oxygen tanks. This device also carries some of the same disadvantages as supplemental oxygen, however, as the bag is also heavy and patients are not ambulatory while using the device. Similar to supplemental oxygen and the portable hyperbaric chamber, there is some evidence that CPAP may improve SpO2 and dyspnea at high and extreme altitudes. CPAP has already demonstrated significant efficacy in reducing symptoms of acute mountain sickness (AMS) when used in the field. At the time these small studies were conducted, CPAP therapy carried similar disadvantages in weight and portability. In recent years, however, CPAP devices have become increasingly lightweight and portable, with recent models weighing less than 1 kilogram (2.2 pounds). These devices are often powered by batteries, which themselves are light and easy to carry, and can be charged in the field using either a generator or foldable solar panels. These newer features of CPAP devices overcome some of the previous disadvantages that have limited its potential uses. CPAP devices can easily be carried across difficult terrain directly to individuals suffering from altitude-related symptoms, to be used as a rescue device until definitive care is available. Its portability not only allows for easy delivery to a patient, but also may allow for a patient to experience enough symptom relief to walk themselves down to lower elevation, greatly improving speed and resource utilization involved in high altitude rescues. In previous studies, CPAP devices have been found to be effective and safe to use in high and extreme altitude locations. While a few pilot studies have assessed CPAP's utility in treating dyspnea and SpO2 at altitude, these studies were done at rest. While one study showed improved symptoms and SpO2 in normobaric and hypobaric hypoxia, the study was limited by its lack of real-world condition, and its authors suggested further study in field and extreme environmental conditions. Additional investigation is needed to determine whether or not CPAP is an effective tool in the field to improve SpO2, dyspnea, and exercise tolerance in individuals traveling at high elevations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Altitude Hypoxia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure use
Arm Type
Experimental
Arm Title
Ambient air
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Intervention Description
Continuous positive airway pressure administered by face mask
Intervention Type
Device
Intervention Name(s)
Ambient air
Intervention Description
Air (fraction of inspired oxygen) at 14000 feet in elevation
Primary Outcome Measure Information:
Title
Peripheral oxygen saturation
Description
SpO2 measurement in percentage
Time Frame
1 day
Title
Respiratory rate
Description
Breaths/minute
Time Frame
1 day
Title
Heart rate
Description
Heartbeats/minute
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults (age 18-70) Living at lower elevation (<2500m or 8200ft) Exclusion Criteria: Age > 70 or age < 18. History of chronic respiratory conditions (asthma, COPD, ILD) Obstructive sleep apnea (if currently using nighttime CPAP) Congestive heart failure, coronary artery disease History of myocardial infarction History of HAPE Neurologic disorder Cognitive disorder Altered mental status Pregnancy Current use of supplemental oxygen Impaired mobility Excessive facial hair Claustrophobia. Current use of altitude-related illness prophylaxis medications Current use of anticoagulant medications Current use of calcium channel blockers medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Strickland, MD
Organizational Affiliation
UC Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude

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