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

NCT ID: NCT04288219

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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High Altitude Pulmonary Edema Non-Invasive Positive Pressure Ventilation Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Standard of Care Treatment

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

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Nifedipine 30mg, Pharmacotherapy

supplemental oxygen

Intervention Type OTHER

supplemental oxygen

Non-Invasive Positive Pressure Ventilation Management

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

Group Type EXPERIMENTAL

Non-Invasive Positive Pressure Ventilation

Intervention Type DEVICE

Continuous positive airway pressure delivered by face mask at 10cmH2O

Nifedipine

Intervention Type DRUG

Nifedipine 30mg, Pharmacotherapy

Interventions

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Non-Invasive Positive Pressure Ventilation

Continuous positive airway pressure delivered by face mask at 10cmH2O

Intervention Type DEVICE

Nifedipine

Nifedipine 30mg, Pharmacotherapy

Intervention Type DRUG

supplemental oxygen

supplemental oxygen

Intervention Type OTHER

Other Intervention Names

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CPAP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Himalayan Rescue Association

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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N. Stuart Harris MD MFA

Chief, Division of Wilderness Medicine, Principal Investigator, Clinical Innstructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Himalayan Rescue Association

Kathmandu, , Nepal

Site Status RECRUITING

Countries

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Nepal

Central Contacts

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N. Stuart Harris, MD, MFA

Role: CONTACT

617-724-3290

Blair A Parry

Role: CONTACT

617-724-4758

Facility Contacts

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Brian Strickland, MD

Role: primary

+977 1-4440293

Other Identifiers

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2019P003234

Identifier Type: -

Identifier Source: org_study_id

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