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

Not Applicable

• Conditions: Respiratory Failure

• Registration Number: NCT02495675
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-04
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-10
• Last Update Submitted: 2015-07-10
• Study First Posted: 2015-07-13
• Last Update Posted: 2015-07-13
• Primary Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Work of breathing	10 minutes	Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).

Secondary Outcome Measures

Name	Time	Method
Blood gases	10 minutes	Arterial or capillary blood gases at the end of each period
Comfort of breathing	10 minutes	Subjective evaluation at the end of each period
Tidal Volume	10 minutes	Measured at the end of each period
End-tidal carbon dioxide	10 minutes	Measured at the end of each period
Dyspnea	10 minutes	Evaluation on a borg scale at the end of each period
Respiratory Rate	10 minutes	Measured at the end of each period
Oxygen saturation	10 minutes	Measured at the end of each period
Esophageal pressure-time product	10 minutes	Measured at the end of each period
Heart rate	10 minutes	Measured at the end of each period

Trial Locations

Locations (1)

Centre de Recherche de l'IUCPQ; 🇨🇦 Québec, Quebec, Canada