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Investigation of Efficiency of Breathing With Different Breathing Patterns

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ClinicalTrials.gov Identifier: NCT00784004
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Physiology Respiratory Insufficiency Breathing Patterns Other: Breathing Patterns Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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U.S. FDA Resources

Arm Intervention/treatment
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:

  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
Patients
Sixteen 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:

  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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784004


Locations
United States, Massachusetts
Massachusetts General Hospital, Respiratory Care Laboratory
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yandong Jiang, Assistant Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00784004     History of Changes
Other Study ID Numbers: 2007-P-001371
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Yandong Jiang, Massachusetts General Hospital:
breathing patterns,
unidirectional breathing,
mask ventilation,
respiratory physiology

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases