Investigation of Efficiency of Breathing With Different Breathing Patterns

December 1, 2014 updated by: Yandong Jiang, Massachusetts General Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital, Respiratory Care Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Volunteers
Ten healthy volunteers

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
Other: Patients
Sixteen patients with respiratory insufficiency

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 31, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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