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

NCT02809807 | Completed DMC

• 1 other identifier: 21140MPOC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Work of Breathing

Keywords

Work of Breathing; Hypoxemia; Respiratory Acidosis; Respiratory effort; COPD

Outcome Measures

Primary Outcomes (1)

• Indexes of respiratory effort

  At rest

  10 minutes

Study Arms (3)

Baseline

EXPERIMENTAL

Without a gas mask. We measure baseline respiratory index, parameters and the comfort.

Other: measurement of the work of breathing

Assessment with gas mask and canister A

EXPERIMENTAL

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; Device: Gas Mask

Assessment with gas mask and canister B

EXPERIMENTAL

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; Device: Gas Mask

Interventions

measurement of the work of breathing OTHER

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.

Assessment with gas mask and canister A; Assessment with gas mask and canister B; Baseline

Gas Mask DEVICE

Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters.

Also known as: Canadian Gas Mask (C4, Airboss Defence, Bromont, Canada) and Canisters (C7A1 and ABD81)

Assessment with gas mask and canister A; Assessment with gas mask and canister B

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD Diagnosis: mild-to-moderate, with FEV1 30-80% and requiring no long-term oxygenotherapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Captain (retired) Stephane Bourassa, RN CD: collaborator
• Mr Pierre-Alexandre Boucard, RT: collaborator

Study Sites (1)

Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Bourassa S, Bouchard PA, Dauphin M, Lellouche F. Oxygen Conservation Methods With Automated Titration. Respir Care. 2020 Oct;65(10):1433-1442. doi: 10.4187/respcare.07240. Epub 2020 Feb 18.

  PMID: 32071135 DERIVED

MeSH Terms

Conditions

Hypoxia; Acidosis, Respiratory; Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Protective Devices

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Francois Lellouche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

CA (1)