Breckenridge Medical Center
Breckenridge, Colorado, 80424, United States
NCT Number: NCT04186598
The primary objective is to evaluate the efficacy of continuous positive pressure on resolution of high-altitude pulmonary edema vs high flow oxygen. The secondary objective is to derive an incidence of high-altitude pulmonary edema based on the elevation and timing from which the subject arrives. Additionally, in a convenience sample of the base study population, an ultrasound evaluation for the presence of B lines in the lungs will be conducted after 2 hours.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Breckenridge, Colorado, 80424, United States
Multicenter, double-blinded, randomized control trial. Enrollment is based on presentation to one of the treating facilities with clinical signs and symptoms of high-altitude pulmonary edema with a recent arrival at high altitude, an oxygen saturation below 85%, and radiographic evidence of noncardiogenic pulmonary edema. A total of 264 patients will be randomized 1:1 across 2 study arms: a CPAP mask set to 15cm H2O and an altered CPAP mask in which the pressure valve has been modified to deliver no positive pressure. All patients will be treated with 30mg nifedipine XR. Except for the application of positive pressure, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms. Patients will be evaluated every 30 minutes for their ability to maintain an oxygen saturation of 92% with a normal respiratory rate and no signs of increased work of breathing on 2 liters of nasal cannula oxygen for a total of up to a maximum treatment length of 2 hours. The primary efficacy endpoint will be assessed every 30 minutes for 2 hours.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention group will receive 15cm of H2O of positive end expiratory pressure
All participants will receive this intervention
Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure
Time frame: 2 hours
The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen
Time frame: 2 hours
A convenience sample of the total study population will have a bedside pulmonary ultrasound at time zero and two hours
Time frame: 2 hours
A descriptive measurement of the time since the patient arrived at altitude until the development of HAPE
Time frame: 2 hours
Data will be collected and analyzed to seek a relationship between the subjects home altitude and the altitude of their sleep while at high altitude
CommonSpirit Health
Other
Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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