The Gas Mask: the Effects on Respiration!
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ClinicalTrials.gov Identifier: NCT02782936 |
Recruitment Status :
Completed
First Posted : May 26, 2016
Last Update Posted : September 29, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Work of Breathing | Other: measurement of the work of breathing Device: Gas mask | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Health Services Research |
Official Title: | Impact of Gas Masks on Index of Efforts and Breathing Pattern |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Baseline
Randomised baseline without and with gas mask.
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Other: measurement of the work of breathing
We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. A gas mask has been used mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter has been introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 has been 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 has been considered for analyses. Device: Gas mask During the conditions that involved a gas mask, the measurement of the work of breathing is achieved with a oesophageal catheter and two disposable pneumotachs. While the oesophageal catheter has been fixed to the mandibular with an hypo-allergic tape, the two pneumotachs are hooked respectively on the canister and exhalation port of the gas mask. Investigators have induced the hypoxemia with a mixture nitreous and medical gas in a plastic bag that has been setted up to the canister. The FiO2 level has been kept to 14 percent.
Other Name: Canadian Gas Mask C-4 manufactured by Airboss Defence, Bromont, Québec, Canada. |
Experimental: Induced Hypoxemia
Randomised hypoxemia: i. without gas mask; ii. with gas mask; and iii. correction with FreeO2 and gas mask.
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Other: measurement of the work of breathing
We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. A gas mask has been used mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter has been introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 has been 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 has been considered for analyses. Device: Gas mask During the conditions that involved a gas mask, the measurement of the work of breathing is achieved with a oesophageal catheter and two disposable pneumotachs. While the oesophageal catheter has been fixed to the mandibular with an hypo-allergic tape, the two pneumotachs are hooked respectively on the canister and exhalation port of the gas mask. Investigators have induced the hypoxemia with a mixture nitreous and medical gas in a plastic bag that has been setted up to the canister. The FiO2 level has been kept to 14 percent.
Other Name: Canadian Gas Mask C-4 manufactured by Airboss Defence, Bromont, Québec, Canada. |
Experimental: Effort
Randomised effort without and with gas mask
|
Other: measurement of the work of breathing
We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. A gas mask has been used mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter has been introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 has been 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 has been considered for analyses. Device: Gas mask During the conditions that involved a gas mask, the measurement of the work of breathing is achieved with a oesophageal catheter and two disposable pneumotachs. While the oesophageal catheter has been fixed to the mandibular with an hypo-allergic tape, the two pneumotachs are hooked respectively on the canister and exhalation port of the gas mask. Investigators have induced the hypoxemia with a mixture nitreous and medical gas in a plastic bag that has been setted up to the canister. The FiO2 level has been kept to 14 percent.
Other Name: Canadian Gas Mask C-4 manufactured by Airboss Defence, Bromont, Québec, Canada. |
- indexes of respiratory effort [ Time Frame: 10 minutes ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782936
Canada, Quebec | |
Institut de recheche universitaire de cardiologie et pneumologie de Québec | |
Québec, Quebec, Canada, G1V4G5 |
Principal Investigator: | Francois Lellouche, Doctorate | Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec |
Responsible Party: | François Lellouche, Physician, Laval University |
ClinicalTrials.gov Identifier: | NCT02782936 |
Other Study ID Numbers: |
21140 2015-2448 ( Other Identifier: CRIUCPQ ) |
First Posted: | May 26, 2016 Key Record Dates |
Last Update Posted: | September 29, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Work of Breathing; Hypoxemia; Respiratory Acidosis; Respiratory effort |
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes |