Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

Poitiers University Hospital1 site in 1 country1,504 target enrollmentJanuary 19, 2021

ConditionsAcute Respiratory Failure Hypoxemic Respiratory Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Failure
Sponsor: Poitiers University Hospital
Enrollment: 1504
Locations: 1
Primary Endpoint: Mortality at 28 days after randomization
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

Registry

clinicaltrials.gov

Start Date

January 19, 2021

End Date

December 31, 2024

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Poitiers University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:
•Respiratory rate \>25 breaths/min whatever the oxygen support
•Pulmonary infiltrate,
•PaO2/FiO2 ≤200 mmHg
•Informed consent from the patient or relatives.

Exclusion Criteria

•PaCO2 \> 45 mm Hg
•Need for emergent intubation: pulse oximetry \< 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
•Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors \> 0.3 µg/kg/min
•Glasgow coma scale equal to or below 12 points
•Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support
•Cardiogenic pulmonary edema as main reason for acute respiratory failure
•Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed)
•Post-extubation respiratory failure within 7 days after extubation,
•Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
•Do not intubate order;

Outcomes

Primary Outcomes

Mortality at 28 days after randomization

Time Frame: Day 28

Death between randomization and 28 days after randomization

Secondary Outcomes

Failure of the oxygenation strategy between randomization and D28(Day 28)
Complications during the ICU stay(Day 90)
Comfort(Hour 6)
Number of ventilation free days at Day 28(Day 28)
Dyspnea(Hour 6)
Duration between treatment initiation and intubation(Day 28)
Level of oxygenation(Hour 48)
Duration between the time when prespecified criteria of intubation are met and intubation(Day 28)
Mortality in ICU, in hospital, and day 90(Day 90)
Duration of ICU and hospital stay(Day 90)
Organ Failure during the 48 hours after intubation.(Day 28)