We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gas Mask and Chronic Obstructive Pulmonary Disease (COPD): New Understanding on the Respiratory Index Impact? (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809807
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborators:
Captain (retired) Stephane Bourassa, RN CD
Mr Pierre-Alexandre Boucard, RT
Information provided by (Responsible Party):
François Lellouche, Laval University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Work of Breathing Other: measurement of the work of breathing Device: Gas Mask Not Applicable

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baseline
Without a gas mask. We measure baseline respiratory index, parameters and the comfort.
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.
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)




Primary Outcome Measures :
  1. Indexes of respiratory effort [ Time Frame: 10 minutes ]
    At rest



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Quebec
Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Captain (retired) Stephane Bourassa, RN CD
Mr Pierre-Alexandre Boucard, RT
Investigators
Layout table for investigator information
Principal Investigator: Francois Lellouche, PhD Laval University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
Keywords provided by François Lellouche, Laval University:
Work of Breathing; Hypoxemia; Respiratory Acidosis; Respiratory effort; COPD
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes