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CompletedNCT03447457Updated Feb 27, 2018

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

An interventional study of High-flow oxygen and Standard oxygen in Acute Respiratory Failure, sponsored by Poitiers University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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%.
02

Conditions studied

  • Acute Respiratory Failure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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,
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Other
    standard oxygen group

    Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir

    Device: Standard oxygen

  • 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

    Device: High-flow oxygen

Interventions

  • DeviceHigh-flow oxygen

    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%

    Also known as: High-flow nasal cannula oxygen therapy

  • DeviceStandard oxygen

    nasal cannula, face mask or non-rebreathing reservoir mask

05

What researchers measure

Primary outcomes

  1. complete regression of respiratory failure

    respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing

    Time frame: one hour after initiation of oxygen strategies

06

Study locations

2 sites
  • CHG de Niort
    Niort, 79000, France
  • CHU Poitiers
    Poitiers, 86000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447457
Lead sponsor
Poitiers University Hospital
Collaborators
Centre Hospitalier de Niort
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Dec 1, 2015
Primary completion
May 30, 2017
Completion
May 30, 2017
Last update
Feb 27, 2018

Study contacts

Jean MACE, MD
study director · Centre Hospitalier de Niort

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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