Gas Mask and Chronic Obstructive Pulmonary Disease (COPD): New Understanding on the Respiratory Index Impact? (COPD)
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ClinicalTrials.gov Identifier: NCT02809807 |
Recruitment Status :
Completed
First Posted : June 22, 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 : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | The Impact of the Work of Breathing and Gas Exchange for COPD Patient Using a Gas Mask. |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Baseline
Without a gas mask. We measure baseline respiratory index, parameters and the comfort.
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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. 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. Comfort has also been assessed. FreeO2 System has been used and pre-programmed in accordance with the patient SpO2 target zone for potential correction of the hypoxemia occurrences. Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters. |
Experimental: Assessment with gas mask and canister A
With a gas mask, the measurement have been done with a high resistive canister. We measure baseline respiratory index, parameters and the comfort. These would serve for conduction comparison with the baseline.
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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. 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. Comfort has also been assessed. FreeO2 System has been used and pre-programmed in accordance with the patient SpO2 target zone for potential correction of the hypoxemia occurrences. Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters. Device: Gas Mask Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters.
Other Name: Canadian Gas Mask (C4, Airboss Defence, Bromont, Canada) and Canisters (C7A1 and ABD81) |
Experimental: Assessment with gas mask and canister B
With a gas mask, the measurement have been done with a low resistive canister. We measure baseline respiratory index, parameters and the comfort. These would serve for conduction comparison with the baseline.
|
Other: measurement of the work of breathing
We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. 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. Comfort has also been assessed. FreeO2 System has been used and pre-programmed in accordance with the patient SpO2 target zone for potential correction of the hypoxemia occurrences. Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters. Device: Gas Mask Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters.
Other Name: Canadian Gas Mask (C4, Airboss Defence, Bromont, Canada) and Canisters (C7A1 and ABD81) |
- Indexes of respiratory effort [ Time Frame: 10 minutes ]At rest

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT02809807
Canada, Quebec | |
Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec | |
Québec, Quebec, Canada, G1V 4G5 |
Principal Investigator: | Francois Lellouche, PhD | Laval University |
Responsible Party: | François Lellouche, Research Director, Laval University |
ClinicalTrials.gov Identifier: | NCT02809807 |
Other Study ID Numbers: |
21140MPOC |
First Posted: | June 22, 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; COPD |
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes |