A Novel Unidirectional Face Mask During NPPV in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00972868
• Other study ID #: 2009P000057
• Status: Withdrawn
• Phase: N/A
• First received: August 27, 2009
• Last updated: January 13, 2017
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in anatomical dead space and improvement in ventilatory efficiency		30 minutes
Secondary	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