Clinical trial NCT00784004: Investigation of Efficiency of Breathing With Different Breathing Patterns
Official title: Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Physiology
Respiratory Insufficiency
Breathing Patterns
Keywords: breathing patterns,
unidirectional breathing,
mask ventilation,
respiratory physiology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
measure: Comparing the efficiency of CO2 removal at given minute ventilations with the four different breathing patterns in patients with chronic respiratory failure.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Respiratory Care Laboratory
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yandong Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.