- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784004
Investigation of Efficiency of Breathing With Different Breathing Patterns
Investigation of Efficiency of Breathing With Different Breathing Patterns in Healthy Volunteers and Patients With Respiratory Failure
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital, Respiratory Care Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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:
- 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.
Study Plan
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:
|
|
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:
|
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-P-001371
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.