Clinical trial NCT02495675: Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects
Official title: Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Work of breathing
timeFrame: 10 minutes
Secondary outcomes:
measure: Esophageal pressure-time product
timeFrame: 10 minutes
measure: Tidal Volume
timeFrame: 10 minutes
measure: Comfort of breathing
timeFrame: 10 minutes
measure: Blood gases
timeFrame: 10 minutes
measure: Dyspnea
timeFrame: 10 minutes
measure: Respiratory Rate
timeFrame: 10 minutes
measure: End-tidal carbon dioxide
timeFrame: 10 minutes
measure: Heart rate
timeFrame: 10 minutes
measure: Oxygen saturation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de Recherche de l'IUCPQ
state: Quebec
Study officials:
affiliation: Fondation IUCPQ
name: François Lellouche, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.