Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients. (HDWOBPT)

This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Oxygen delivery via conventional nasal mask; Device: Airvo 2; Ficher and Paykel HealthCare

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 PaCO2. 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.

The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with

• either hypoxemia (SpO2<90% with O2≥3L/min) ;
• or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38).

Exclusion Criteria:

• Patients below 18yo, pregnant or breastfeeding women;
• Patients enrolled in another study excluding co-enrolment;
• 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;
• Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
• Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30;
• Patient 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional flow via nasal prongs; Oxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition.	Device: Oxygen delivery via conventional nasal mask; Low flow of oxygen delivered through conventional nasal prongs
Experimental: High flow nasal cannulas 20L/min; Oxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition.	Device: Airvo 2; Ficher and Paykel HealthCare; High flow nasal cannulas
Experimental: High flow nasal cannulas 40L/min; Oxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.	Device: Airvo 2; Ficher and Paykel HealthCare; High flow nasal cannulas
Experimental: High flow nasal cannulas 60L/min; Oxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition.	Device: Airvo 2; Ficher and Paykel HealthCare; High flow nasal cannulas

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)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal pressure-time product	Measured at the end of each period	15 minutes
Tidal volume	Measured at the end of each period	15 minutes
Comfort of breathing	Subjective evaluation at the end of each period	15 minutes
Blood gases	Arterial or capillary blood gases at the end of each period	15 minutes
Dyspnea	Evaluation on a borg scale at the end of each period	15 minutes
Respiratory rate	Measured at the end of each period	15 minutes
Heart rate	Measured at the end of each period	15 minutes
End-tidal carbon dioxide	Measured at the end of each period	15 minutes
Oxygen saturation	Measured at the end of each period	15 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 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-HDWOBPT