Investigation of Efficiency of Breathing With Different Breathing Patterns - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00784004

Purpose

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.

Condition	Intervention
Respiratory Physiology Respiratory Insufficiency Breathing Patterns	Other: Breathing Patterns

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Volunteers Ten healthy volunteers	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
Patients Twenty patients with respiratory insufficiency	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784004

Contacts

Contact: Yandong Jiang, MD, PhD	617-7242366	yjiang@partners.org
Contact: Robert M Kacmarek, PhD	617-7244480	rkacmarek@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital, Respiratory Care Laboratory	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert M Kacmarek, PhD 617-724-4480 rkacmarek@partners.org

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Yandong Jiang, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Yandong Jiang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00784004 History of Changes
Other Study ID Numbers:	2007-P-001371
Study First Received:	October 30, 2008
Last Updated:	July 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

breathing patterns,
unidirectional breathing,
mask ventilation,
respiratory physiology

Additional relevant MeSH terms:

Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders

Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012