Work of Breathing Clinical Trial
— COPDOfficial title:
The Impact of the Work of Breathing and Gas Exchange for COPD Patient Using a Gas Mask.
Verified date | September 2016 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Background: The gas mask is used to protect the aiways against respiratory hazards (CBRN agents). Within the CBRNE committee, speculations are that unprotected lungs would look like to those of COPD patients in post-exposure of some CBRNE agents. The aim of the study was to evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory effort. Methods: We are completing our study with 9 COPD patients to evaluate breathing patterns, index of respiratory efforts and blood gases. Three conditions have been tested in a randomized order: 1x baseline and 2x different canisters, with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter is introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 is continuously measured and capillary blood bases are drawn at the end of each condition. Each condition lasts 10 minutes, data of the last 2 minutes at a steady state are considered for analyses. Results. We are compiling data and processing them for analysis.
Status | Completed |
Enrollment | 9 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: • COPD Diagnosis: mild-to-moderate, with FEV1 30-80% and requiring no long-term oxygenotherapy. Exclusion Criteria: - Refuse to participate in the study for one of the following reasons: i. wearing a oesophageal catheter; ii. wearing the gas mask; iii. giving blood sample; iv. claustrophobia. - Oesophageal background wounds - Facial anthropometrical issues. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Captain (retired) Stephane Bourassa, RN CD, Mr Pierre-Alexandre Boucard, RT |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indexes of respiratory effort | At rest | 10 minutes | Yes |
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