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Work of BreathingNCT02782936

The Gas Mask: the Effects on Respiration!

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 military and non-military subjects exposed to respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory effort. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
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
15 participants
Where
1 siteCanada
Study dates
Jun 2015to 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

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 recheche universitaire de cardiologie et pneumologie de Québec

    Québec, Quebec, G1V4G5

Other trials in Canada

About this study

Official title: Impact of Gas Masks on Index of Efforts and Breathing Pattern

Background: The gas mask is used to protect military and non-military subjects exposed to respiratory hazards (CBRN 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 14 healthy subjects to evaluate breathing patterns, index of respiratory efforts and blood gases. Seven conditions have been tested in a randomized order: at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows were measured. An esophageal catheter was introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 was 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 were considered for analyses. Results: The preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the gas mask and without, most of the respiratory index increased in the tested conditions (at rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject the indexes of effort were higher with the gas mask, a statistical trend was observed with the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s; p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04; SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern and arterial blood gases data with and without mask. Data for induced hypoxemia are under analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O at 1 L/sec). This may explain in part the increased work of breathing with masks. Conclusions: This study demonstrated an increase of the indexes of respiratory effort during an exercise with the gas mask. This study is the first to directly assess the indexes of efforts with esophageal pressure in this situation. Our results and method may be used as a reference for evaluating tolerance with different designs of gas masks.

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).

The gas mask design and its components may lead to these respiratory load issues. At rest and effort, 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: i. on a 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 at both at rest and effort.

Our goal was to measure the impact of the work of breathing and the gas exchange for a gas mask user. We also measured what was the optimal means for correcting the hypoxemia with a subject.

14 Male Human Subjects participated in a comparison and single-blind randomized experimental study. That was approved by the Ethical Review Committee. All male subjects were in averaged age of 38.9±5 year old and a FEV1 4.60±0.70 Liter. A written consent was obtained for all the subjects prior their acceptance. No rejection happened during the recruiting. The eligibility criteria were: i. No significant cardiac and respiratory diseases known; ii. No epilepsy background; iii. No severe pathology requiring medication; iv. No pregnancy for woman; v. Face medium - size in relation of the gas mask. The exclusion criteria were: 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 was also done before starting the clinical trial.

Design comprised seven 10-minute testing conditions split in two parts. Five were at rest and sitting on a chair: i. Baseline without gas mask; ii. Baseline with gas mask; iii. Hypoxemia without mask; iv. Hypoxemia with gas mask; and v. Hypoxemia corrected. Two effort conditions were programmed at 7 METS Effort Zone and were performed on Treadmill (Constant 3 MPH speed and 10% inclination). These were with and without the gas mask. Between the rest-condition a 5-minute wash-out took place while for the effort a ten-minute was applied.

Three five-minute periods was followed to record blood pressure and pulse during the conditions. SpO2 was continuously measured with Free O2 during condition while the Massimo was employed also at the beginning both the inclusion and at the each three hypoxemia condition (Radical - Signal Extraction Pulse Oximeter). During effort, they were taken at each two-minute, starting at a zero starting point. Capillary punctures were done at the end of each condition.

Our main measurements were the WOB performed with a continuous recording of Peso pressure and respiratory volumes. Software Acknowledge, version 3.9 served as acquisition data system and analysis were achieved with a 4.2 version and a free-trial WOB calculus system, named RESPMAT. That was obtained from Maynaud and al. [2]. As power source, we used a BIOPAC (MP100, Santa Barbara, Californie, USA, 200 Hertz), four differential sensors (Validyne : 1x MP45±100 cmH2O; 2x MP??±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 were used. Lidocain spray and K-Y gel were applied during the insertion of the catheter. Its placement was done at 37.6±5.7 cm across the subject and a Mueller test was performed for each subject. In regard of spontaneous breathing, an Hudson mask was used while a C-4 Gas Mask with a canister was employed (Manufacturer: Airboss Defence, Bromont, Canada). Hypoxemia mixture was home-design with usual nitrous and medical gas and maintaining a FiO2 target at 14%. Prototyped Free O2 System was 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
Medical subject headings
Hypoxia, Acidosis, Respiratory

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. 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.

  • Gas maskDevice

    Also called Canadian Gas Mask C-4 manufactured by Airboss Defence, Bromont, Québec, Canada.

    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.

Study groups in NCT02782936
Study groupRoleWhat they receive
BaselineExperimentalRandomised baseline without and with gas mask.
Receives: Other: measurement of the work of breathing; Device: Gas mask
Induced HypoxemiaExperimentalRandomised hypoxemia: i. without gas mask; ii. with gas mask; and iii. correction with FreeO2 and gas mask.
Receives: Other: measurement of the work of breathing; Device: Gas mask
EffortExperimentalRandomised effort without and with gas mask
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

    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.

    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 posted26 May 2016 (estimated)
  2. Study startJun 2015
  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
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02782936
Sponsor's protocol ID
21140
Other IDs
2015-2448
Status last verified
Sep 2016
First submitted
19 May 2016
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
No
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
  • Bourassa S, Bouchard PA, Lellouche F. Impact of Gas Masks on Work of Breathing, Breathing Patterns, and Gas Exchange in Healthy Subjects. Respir Care. 2018 Nov;63(11):1350-1359. doi: 10.4187/respcare.06027. Epub 2018 Jul 31.

    PubMed 30065082

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 5 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 NCT02782936, which also lists 2 linked publications.

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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