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

NCT ID: NCT02494154

Last Updated: 2015-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Oxygen delivery via conventional nasal mask

Intervention Type DEVICE

Low flow of oxygen delivered through conventional nasal prongs

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.

Group Type EXPERIMENTAL

Airvo 2; Ficher and Paykel HealthCare

Intervention Type DEVICE

High flow nasal cannulas

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.

Group Type EXPERIMENTAL

Airvo 2; Ficher and Paykel HealthCare

Intervention Type DEVICE

High flow nasal cannulas

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.

Group Type EXPERIMENTAL

Airvo 2; Ficher and Paykel HealthCare

Intervention Type DEVICE

High flow nasal cannulas

Interventions

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Airvo 2; Ficher and Paykel HealthCare

High flow nasal cannulas

Intervention Type DEVICE

Oxygen delivery via conventional nasal mask

Low flow of oxygen delivered through conventional nasal prongs

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Lellouche, MD, PhD

Role: STUDY_DIRECTOR

Fondation IUCPQ

Locations

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IUCPQ

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mathieu Delorme, PT, MSc

Role: CONTACT

418-656-8711 ext. 3508

François Lellouche, MD, PhD

Role: CONTACT

418-656-8711 ext. 3298

Facility Contacts

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François Lellouche, MD, PhD

Role: primary

418-656-8711 ext. 3298

Other Identifiers

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IUCPQ-HDWOBPT

Identifier Type: -

Identifier Source: org_study_id

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