Investigation of Efficiency of Breathing With Different Breathing Patterns

Respiratory Insufficiency Clinical Trial

Official title:

Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784004
• Other study ID #: 2007-P-001371
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: December 1, 2014
• Start date: November 2007
• Est. completion date: June 2011

Study information

• Verified date: December 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Our aim in this study is to investigate the efficiency of the breathing with different breathing patterns. Ten volunteers and twenty patients having respiratory problems will be coached on their breathing through specific masks which will provide four different breathing patterns. These patterns will be 1) Breathing in through the nose only and out through the mouth only 2) Breathing in through the mouth only and out through the nose only 3) Breathing in and out through the nose only 4) Breathing in and out through the mouth only The data obtained from volunteers and patients will be compared within and between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For healthy subjects:

1. Ten healthy adult (> 18 years of age) volunteers will be recruited from the MGH main campus through intra-hospital e-mail broadcasting. Subjects with the following issues will be excluded from the study.

• For patients with respiratory insufficiency:

1. Twenty adult (> 18 years of age) patients will be recruited. These patients will be either patients in acute respiratory failure resulting from COPD exacerbation breathing spontaneously only receiving nasal oxygen admitted to the medical floors of the MGH; or patients with diagnosed stable COPD on home oxygen therapy seen by pulmonary physicians in the outpatient clinics or coming to the MGH as study subjects.

Exclusion Criteria:

• For healthy volunteers:

1. Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;

2. Subjects who have claustrophobia and cannot wear the mask.

• For patients with respiratory insufficiency:

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 requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breathing Patterns
• Pulmonary Valve Insufficiency
• Respiratory Aspiration
• Respiratory Insufficiency
• Respiratory Physiology

Intervention

Other:
• Breathing Patterns
All subjects will breathe in four different breathing patterns which are provided by specific masks. Patterns are as the following: Breathing in through the nose only and out through the mouth only Breathing in through the mouth only and out through the nose only Breathing in and out through the nose only Breathing in and out through the mouth only

Locations

Country	Name	City	State
United States	Massachusetts General Hospital, Respiratory Care Laboratory	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	Determining the anatomic dead space change at variable tidal volumes with four different breathing patterns (nose-in and nose-out, mouth-in and mouth-out, nose-in and mouth-out, mouth-in and nose-out) in healthy volunteers.		3 months	No
Primary	Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.		6 months	No
Secondary	Comparing the efficiency of the study mask which forces subjects to breathe in a manner similar to pursed lip breathing and a regular facemask in healthy volunteers and patients with respiratory failure		6 months	No