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

NCT04186598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Continuous Positive Airway Pressure
  • High Altitude Pulmonary Edema

Interventions

DEVICE

CPAP mask system

Intervention group will receive 15cm of H2O of positive end expiratory pressure

DRUG

Nifedipine 30 MG

All participants will receive this intervention

DEVICE

CPAP mask system without PEEP

Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure

Sponsors & Collaborators

  • Pulmodyne, Inc.

    collaborator UNKNOWN

  • CommonSpirit Health

    lead OTHER

Principal Investigators

  • Todd Bolotin, MD · CommonSpirit Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2023-09-13
Completion
2023-09-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04186598 on ClinicalTrials.gov