Recruiting

High Flow Nasal Cannula

Sponsor:

Laval University

Code:

NCT02494154

Conditions

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Airvo 2; Ficher and Paykel HealthCare

Oxygen delivery via conventional nasal mask

Study Details

Brief summary:

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.

Conditions

Respiratory Failure

Study ID

NCT02494154

Start date

May, 2015

Status verified date

Jul, 2015

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Airvo 2; Ficher and Paykel HealthCare

High flow nasal cannulas

Oxygen delivery via conventional nasal mask

Low flow of oxygen delivered through conventional nasal prongs

Primary outcome measure

  • Work of breathing [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Mathieu Delorme, PT, MSc

418-656-8711mathieu.delorme.2@ulaval.ca

François Lellouche, MD, PhD

418-656-8711francois.lellouche@criucpq.ulaval.ca

Locations

IUCPQ

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

François Lellouche, MD, PhD

418-656-8711francois.lellouche@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jul 10, 2015

Last verified

Jul, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2015-07-10.