Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04186598

Evaluating the Utility of Continuous Positive Airway Pressure in the Treatment of High Altitude Pulmonary Edema

Continuous Positive Airway Pressure Clinical Trial

Official title:
Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04186598
Study type Interventional
Source Centura Health
Contact
Status Completed
Phase N/A
Start date January 20, 2020
Completion date September 13, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04306835 - The Impact of CBT-i on CPAP Therapy Use and Drop Outs in OSAS Patients With Insomnia. N/A
Completed NCT03221205 - Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients N/A
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Recruiting NCT05679635 - Evaluation of Tracheal Pressure During CPAP N/A
Terminated NCT02999165 - Breastfeeding Infants Receiving Respiratory Support Trial
Active, not recruiting NCT06168682 - Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy N/A
Recruiting NCT05369845 - Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome N/A
Completed NCT01326975 - Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants N/A
Completed NCT01096433 - Circadian Variations of Prostaglandin in Sleep Apnea N/A
Completed NCT03151317 - Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
Not yet recruiting NCT04747535 - Continuous Positive Airway Pressure After Abdominal Surgery N/A
Completed NCT03432390 - Positive Pressure at Induction of Anesthesia in Children N/A
Active, not recruiting NCT01312168 - Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment N/A
Terminated NCT00482040 - Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity N/A
Terminated NCT02168257 - Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates N/A
Recruiting NCT03169491 - Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS N/A
Completed NCT01223274 - Delivery Room CPAP in Extremely Low Birth Weight Infants Phase 1/Phase 2
Completed NCT00780923 - Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea N/A
Completed NCT03782844 - Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea N/A
Recruiting NCT02324530 - Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy Phase 2