A Novel Unidirectional Face Mask During NPPV in COPD Patients

NCT00972868 | Withdrawn

• 1 other identifier: 2009P000057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Unidirectional mask; NPPV; COPD; respiratory physiology

Outcome Measures

Primary Outcomes (1)

• Reduction in anatomical dead space and improvement in ventilatory efficiency

  30 minutes

Secondary Outcomes (1)

• Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.

  30 minutes

Study Arms (1)

COPD

EXPERIMENTAL

Thirty adult (\> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)

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

Interventions

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

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.

COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Requiring NPPV as assessed by the managing care team.

You may not qualify if:

• Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
• Patients who have claustrophobia and cannot wear the mask;
• Patients who are hemodynamically unstable;
• Patients who are disoriented and unable to cooperate with the study procedure;
• DNI or DNR status or patients in whom intubation is contraindicated;
• Patients who are currently intubated;
• Patients who recently (\< 6months) had an MI or stroke;

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Robert Kacmarek, PhD, RRT

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 9, 2009
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

US (1)