Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects

NCT ID: NCT02495675

Last Updated: 2015-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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This study evaluates the work of breathing among healthy subjects under various conditions of treatment with high flow nasal cannulas. Ten subjects will be included. The design of this study is a cross over of five treatment periods with different flow settings.

Detailed Description

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High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in carbone dioxyde arterial pressure. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing among healthy subjects. The investigators will evaluate the baseline status in room air, and then compare it with four different levels of flow. The primary endpoint will be the work of breathing.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No flow

Subjects will be spontaneously breathing in room air with no flow.

Group Type NO_INTERVENTION

No interventions assigned to this group

Conventional flow via nasal prongs

Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)

Group Type EXPERIMENTAL

Conventional flow via nasal prongs

Intervention Type DEVICE

Low flow of air delivered through conventional nasal prongs

High flow nasal cannulas 20 L/min

Subjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.

Group Type EXPERIMENTAL

High flow nasal cannulas

Intervention Type DEVICE

Comparison of different flow levels

High flow nasal cannulas 40 L/min

Subjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.

Group Type EXPERIMENTAL

High flow nasal cannulas

Intervention Type DEVICE

Comparison of different flow levels

High flow nasal cannulas 60 L/min

Subjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.

Group Type EXPERIMENTAL

High flow nasal cannulas

Intervention Type DEVICE

Comparison of different flow levels

Interventions

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High flow nasal cannulas

Comparison of different flow levels

Intervention Type DEVICE

Conventional flow via nasal prongs

Low flow of air delivered through conventional nasal prongs

Intervention Type DEVICE

Other Intervention Names

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Airvo 2; Ficher and Paykel HealthCare

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Written and informed consent

Exclusion Criteria

* Pregnant or breastfeeding women;
* Subject enrolled in another study excluding co-enrolment;
* Cardio-vascular or respiratory disease;
* History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
* Subject feeling nauseous or under recent fed condition (\<1h).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Lellouche, MD, PhD

Role: STUDY_DIRECTOR

Fondation IUCPQ

Locations

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Centre de Recherche de l'IUCPQ

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mathieu Delorme, PT, MSc

Role: CONTACT

418-656-8711 ext. 3508

François Lellouche, MD, PhD

Role: CONTACT

418-656-8711 ext. 3298

Facility Contacts

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François Lellouche, MD, PhD

Role: primary

418-656-8711 ext. 3298

References

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Delorme M, Bouchard PA, Simon M, Simard S, Lellouche F. Physiologic Effects of High-Flow Nasal Cannula in Healthy Subjects. Respir Care. 2020 Sep;65(9):1346-1354. doi: 10.4187/respcare.07306. Epub 2020 Apr 14.

Reference Type DERIVED
PMID: 32291309 (View on PubMed)

Other Identifiers

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IUCPQ-HDWOBSS

Identifier Type: -

Identifier Source: org_study_id

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