Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

Poitiers University Hospital1,504 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,504

Conditions

Acute Respiratory Failure Hypoxemic Respiratory Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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; * Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome. * Patients without any healthcare insurance scheme or not benefiting from it through a third party, * Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Outcomes

Primary Outcomes

Mortality at 28 days after randomization

Death between randomization and 28 days after randomization

Time frame: Day 28

Secondary Outcomes

Failure of the oxygenation strategy between randomization and D28

Intubation between randomization and D28

Time frame: Day 28

Mortality in ICU, in hospital, and day 90

Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.

Time frame: Day 90

Number of ventilation free days at Day 28

days alive and without intubation between day 1 and day 28

Time frame: Day 28

Duration of ICU and hospital stay

ICU and hospital stay between randomisation and end of stay in ICU and hospital

Time frame: Day 90

Complications during the ICU stay

Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.

Time frame: Day 90

Dyspnea

feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)

Time frame: Hour 1

Comfort

comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"

Time frame: Hour [1;6]

Level of oxygenation

Oxygenation is assessed by arterial blood gas sample

Time frame: Hour [1;6]

Organ Failure during the 48 hours after intubation.

Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.

Time frame: Day 28

Duration between the time when prespecified criteria of intubation are met and intubation

interval between the time when prespecified criteria of intubation are met and intubation

Time frame: Day 28

Duration between treatment initiation and intubation

Interval between treatment initiation and intubation

Time frame: Day 28

Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes