Work of Breathing Clinical Trial
Official title:
Impact of Gas Masks on Index of Efforts and Breathing Pattern
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 military and non-military subjects exposed to respiratory hazards (CBRN 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 14 healthy subjects to evaluate breathing patterns, index of respiratory efforts and blood gases. Seven conditions have been tested in a randomized order: at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows were measured. An esophageal catheter was introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data of the last 2 minutes at a steady state were considered for analyses. Results: The preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the gas mask and without, most of the respiratory index increased in the tested conditions (at rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject the indexes of effort were higher with the gas mask, a statistical trend was observed with the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s; p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04; SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern and arterial blood gases data with and without mask. Data for induced hypoxemia are under analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O at 1 L/sec). This may explain in part the increased work of breathing with masks. Conclusions: This study demonstrated an increase of the indexes of respiratory effort during an exercise with the gas mask. This study is the first to directly assess the indexes of efforts with esophageal pressure in this situation. Our results and method may be used as a reference for evaluating tolerance with different designs of gas masks.
Status | Completed |
Enrollment | 15 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion - Having no significant cardiac and respiratory pathology - Having no history of epilepsy - Having no severe and chronic pathology that requires medication - Not being pregnant - Face size: medium Exclusion - 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: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | Institut de recheche universitaire de cardiologie et pneumologie de Québec | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Captain (Ret) Stephane Bourassa, RN., Pierre-Alexandre Bouchard, RT. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | indexes of respiratory effort | In this study, we speculate the work of breathing is increasing with the use of a gas mask at rest, under hypoxemia condition and during physical effort. | 10 minutes | Yes |
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