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WITHDRAWNNANCT00972868

A Novel Unidirectional Face Mask During NPPV in COPD Patients

The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth...

Lead sponsor: Massachusetts General Hospital•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Massachusetts General Hospital

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 \> 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
•2. Requiring NPPV as assessed by the managing care team.

Exclusion Criteria

•1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
•2. Patients who have claustrophobia and cannot wear the mask;
•3. Patients who are hemodynamically unstable;
•4. Patients who are disoriented and unable to cooperate with the study procedure;
•5. DNI or DNR status or patients in whom intubation is contraindicated;
•6. Patients who are currently intubated;
•7. Patients who recently (\< 6months) had an MI or stroke;
•8. Pregnant woman; There will be no exclusion based on gender, race or ethnicity.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 16, 2017Terms

Trial snapshot

StatusWITHDRAWN

PhaseNA

Enrollment—

Start dateMar 2011

Last updatedJan 16, 2017

Condition

Chronic Obstructive Pulmonary Disease

Locations shown

Massachusetts General Hospital

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2017Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions