NCT00784004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

3.6 years

First QC Date

October 30, 2008

Last Update Submit

December 1, 2014

Conditions

Keywords

breathing patterns,unidirectional breathing,mask ventilation,respiratory physiology

Outcome Measures

Primary Outcomes (2)

  • 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

  • Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.

    6 months

Secondary Outcomes (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

    6 months

Study Arms (2)

Volunteers

OTHER

Ten healthy volunteers

Other: Breathing Patterns

Patients

OTHER

Sixteen patients with respiratory insufficiency

Other: Breathing Patterns

Interventions

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

PatientsVolunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For healthy subjects:
  • \. 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:
  • 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.

You may not qualify if:

  • For healthy volunteers:
  • Subjects with facial deformity, heavy beard or moustache which prevents good seal between the mask and the face;
  • Subjects who have claustrophobia and cannot wear the mask.
  • For patients with respiratory insufficiency:
  • Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
  • Patients who have claustrophobia and cannot wear the mask.
  • Patients who are hemodynamically unstable.
  • Patients requiring continuous noninvasive positive pressure ventilation or endotracheal intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital, Respiratory Care Laboratory

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Sulemanji DS, Bao F, Jiang Y, Kacmarek RM. A unidirectional breathing pattern improves breathing efficiency in subjects with severe COPD. Respir Care. 2014 Oct;59(10):1487-93. doi: 10.4187/respcare.02899. Epub 2014 Apr 29.

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Yandong Jiang, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

October 30, 2008

First Posted

November 3, 2008

Study Start

November 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations