Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

February 26, 2018 updated by: Poitiers University Hospital
The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

Study Overview

Status

Completed

Detailed Description

Prospective observational before-after study at the ED in two French centers.

Selection of patients with acute hypoxemic respiratory failure at the ED.

Application of oxygen strategy according to the period:

  • before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%.
  • after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Niort, France, 79000
        • CHG de Niort
      • Poitiers, France, 86000
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • de novo acute respiratory failure cowith the following criteria: a respiratory rate > 25 b/min, or signs of increased work of breathing.

Main exclusion Criteria:

  • cardiogenic pulmonary edema,
  • acute exacerbation of chronic lung disease, respiratory acidosis (pH < 7.35 and PaCO2 > 50 mm Hg),
  • hemodynamic instability
  • Glasgow Coma Scale score of 12 points or less,
  • an urgent need for endotracheal intubation,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: standard oxygen group
Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir
nasal cannula, face mask or non-rebreathing reservoir mask
Other: High-flow oxygen group
Patients are treated with high-flow nasal cannula oxygen continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min
HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%
Other Names:
  • High-flow nasal cannula oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete regression of respiratory failure
Time Frame: one hour after initiation of oxygen strategies
respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing
one hour after initiation of oxygen strategies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jean MACE, MD, Centre Hospitalier de Niort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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