Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04288219

Collaborator

Himalayan Rescue Association (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Condition or Disease	Intervention/Treatment	Phase
High Altitude Pulmonary Edema Non-Invasive Positive Pressure Ventilation Hypoxia	Device: Non-Invasive Positive Pressure Ventilation Drug: Nifedipine Other: supplemental oxygen	N/A

Detailed Description

Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

No masking will be done, as the CPAP device will be visible to both participants and investigators

Primary Purpose:

Treatment

Official Title:

Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Treatment Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.	Drug: Nifedipine Nifedipine 30mg, Pharmacotherapy Other: supplemental oxygen supplemental oxygen
Experimental: Non-Invasive Positive Pressure Ventilation Management CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.	Device: Non-Invasive Positive Pressure Ventilation Continuous positive airway pressure delivered by face mask at 10cmH2O Other Names: CPAP Drug: Nifedipine Nifedipine 30mg, Pharmacotherapy

Arm

Intervention/Treatment

Active Comparator: Standard of Care Treatment

Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.

Drug: Nifedipine

Nifedipine 30mg, Pharmacotherapy

Other: supplemental oxygen

supplemental oxygen

Experimental: Non-Invasive Positive Pressure Ventilation Management

CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.

Device: Non-Invasive Positive Pressure Ventilation

Continuous positive airway pressure delivered by face mask at 10cmH2O

Other Names:

CPAP

Drug: Nifedipine

Nifedipine 30mg, Pharmacotherapy

Outcome Measures

Primary Outcome Measures

Oxygen saturation [Up to 4 hours]
Displayed on pulse oximeter

Secondary Outcome Measures

Ultrasonographic assessment of pulmonary edema [Up to 4 hours]
Quantification of B-lines
Subjective rating of dyspnea [Up to 4 hours]
Based on Dypnea Severity Scale (DSS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adults (age 18-80)
Travel through Pheriche, Nepal
Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound

Exclusion Criteria:

History of chronic respiratory conditions (asthma, COPD, ILD)
Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
Kidney disease
Neurologic disorder
Cognitive disorder
Temporary altered mental status
Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
Age under 18 or over 80
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Himalayan Rescue Association	Kathmandu		Nepal

Sponsors and Collaborators

Massachusetts General Hospital
Himalayan Rescue Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

N. Stuart Harris MD MFA, Chief, Division of Wilderness Medicine, Principal Investigator, Clinical Innstructor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT04288219

Other Study ID Numbers:

2019P003234

First Posted:

Feb 28, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Altitude Sickness

Pulmonary Edema

Hypertension, Pulmonary

Edema

Hypoxia

Nifedipine

Study Results

No Results Posted as of Sep 3, 2020