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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Conventional flow via nasal prongs; Device: High flow nasal cannulas

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • Centre de recherche de l'IUCPQ
      • Contact: François Lellouche, MD, PhD; Phone Number: 3298 418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No flow; Subjects will be spontaneously breathing in room air with no flow.
Experimental: Conventional flow via nasal prongs; Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)	Device: Conventional flow via nasal prongs; Low flow of air delivered through conventional nasal prongs
Experimental: 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.	Device: High flow nasal cannulas; Comparison of different flow levels; Other Names: Airvo 2; Ficher and Paykel HealthCare
Experimental: 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.	Device: High flow nasal cannulas; Comparison of different flow levels; Other Names: Airvo 2; Ficher and Paykel HealthCare
Experimental: 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.	Device: High flow nasal cannulas; Comparison of different flow levels; Other Names: Airvo 2; Ficher and Paykel HealthCare

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Study Director: François Lellouche, MD, PhD, Fondation IUCPQ

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 10, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IUCPQ-HDWOBSS