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A Novel Unidirectional Face Mask During NPPV in COPD Patients

NCT00972868 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-16

No results posted yet for this study

Summary

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 and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).

Conditions

Interventions

DEVICE

A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)

The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Yandong Jiang, MD, PhD · Massachusetts General Hospital

  • Robert Kacmarek, PhD, RRT · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00972868 on ClinicalTrials.gov