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Work of BreathingCOPDNCT02809807

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

A study testing measurement of the work of breathing and Gas Mask in people with Work of Breathing, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Work of Breathing
What is being tested?
measurement of the work of breathing and Gas Mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteCanada
Study dates
Jun 2016to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Institut de Recherche Universitaire de Cardiologie et Pneumologie de Québec

    Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: The Impact of the Work of Breathing and Gas Exchange for COPD Patient Using a Gas Mask.

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.

Read the detailed description

The principal way of penetration of CBRNE agents is the respiratory system. The current technology of a gas mask has been used to protect the respiratory system as far back as the First World War. That originated from Dr Cluny Macpherson's initiatives whom was a Canadian military physician.

The military gas mask is part of the respirator classification but owes its specific features. Conventionally, the military gas mask covers a large spectrum of protection aspects and matched with their specific canisters. Consequently, gas masks are usually studied separately from other respirators and Self-Contained Breathing Apparatus (SBCA). While few studies have been about the gas mask technology, no-study addresses it in regards of the impact from a bad airway protection and consequences on the respiratory system.

The gas mask design and its components may lead to these respiratory load issues. At rest and from different resistances, what would be the impacts for the work of breathing and gas exchange? In order to avoid hypoxemia and hyperoxia, what would be the optimal means to restore proper oxygenation? We hypothesised on a: i. Heightened WOB and the respiratory demands related to wear of the gas mask; ii. An occurrence of hypoxemia will be manifesting during a continuous period. Our goal is to measure the impact of the work of breathing and the gas exchange for a gas mask user and also a COPD patient. We also measure what was the optimal means for correcting the hypoxemia with a subject.

9 COPD patients have been participating in a comparison and single-blind randomized experimental study. That was approved by the Ethical Review Committee. A written consent is obtained for all the subjects prior their acceptance. No rejection has happened during the recruiting so far. The eligibility criteria are: i. COPD diagnosis from mild-to-severe FEV 30-80%). The exclusion criteria are: i. Refusals relate to wear the oesophageal catheter and for capillary punctures; ii. Claustrophobia; iii. Oesophageal wounds backgrounds; iv. No coronary background and stroke history; v. No face morphology incompatibility with the mask. Spirometry and usual health screening is also done before starting the clinical trial.

Design comprises three 10-minute testing conditions split in two parts. All has been at rest and sitting on a chair: i. Baseline without gas mask; ii. Gas mask and Canister A; iii. Gas Mask and Canister B. Between the condition a 5-minute wash-out takes place.

Three five-minute periods is followed to record blood pressure and pulse during the conditions. SpO2 is continuously measured with Free O2. Capillary punctures are done at the end of each condition. Comfort was also assessed.

Our main measurements are the WOB performed with a continuous recording of Peso pressure and respiratory volumes. Software Acknowledge, version 3.9 serves as acquisition data system and analysis are achieved with a 4.2 version and a free-trial WOB calculus system, named RESPMAT. That is obtained from Maynaud and al.(2014). As power source, we use a BIOPAC (MP100, Santa Barbara, Californie, USA, 200 Hertz), four differential sensors (Validyne : 1x MP45±100 cmH2O; 2x MP100±5 cmH2O; 1x MP100±100 cmH2O) and four Carrier D-Modulators (Validyne, CT-15,120 Volt, 60 Hertz, 5Watts, Model CD15-A-2-A-1).

Single esophageal catheter (Type Cooper, French caliber #5) and disposable pneumotachs are used. Lidocain spray and K-Y gel are applied during the insertion of the catheter. Its placement is done at 37.6±5.7 cm across the subject and a Mueller test is performed for each subject. In regard of spontaneous breathing, an Hudson mask is used while a C-4 Gas Mask with a canister was employed (Manufacturer: Airboss Defence, Bromont, Canada). Canister A and B were respectively a C7A1 and ADB81 trademark. Prototyped Free O2 System is employed for the correction of the hypoxemia.

Being tested
measurement of the work of breathing, Gas Mask
Keywords
Work of Breathing; Hypoxemia; Respiratory Acidosis; Respiratory effort; COPD
Medical subject headings
Hypoxia, Acidosis, Respiratory, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measurement of the work of breathingOther

    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.

  • Gas MaskDevice

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

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

Study groups in NCT02809807
Study groupRoleWhat they receive
BaselineExperimentalWithout a gas mask. We measure baseline respiratory index, parameters and the comfort.
Receives: Other: measurement of the work of breathing
Assessment with gas mask and canister AExperimentalWith 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.
Receives: Other: measurement of the work of breathing; Device: Gas Mask
Assessment with gas mask and canister BExperimentalWith 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.
Receives: Other: measurement of the work of breathing; Device: Gas Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Indexes of respiratory effort

    At rest

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02809807
Sponsor's protocol ID
21140MPOC
Acronym
COPD
Status last verified
Sep 2016
First submitted
20 Jun 2016
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32071135

Questions about this trial

What is this clinical trial studying?

A study testing measurement of the work of breathing and Gas Mask in people with Work of Breathing, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Indexes of respiratory effort (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02809807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.

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