Clinical trial NCT04468126: Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Hypoxemic Respiratory Failure
Keywords: acute hypoxemic respiratory failure
de novo respiratory failure
high-flow nasal oxygen
standard oxygen
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 1110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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;
* 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.

Primary outcomes:
measure: Mortality at 28 days after randomization
timeFrame: Day 28
Secondary outcomes:
measure: Failure of the oxygenation strategy between randomization and D28
timeFrame: Day 28
measure: Mortality in ICU, in hospital, and day 90
timeFrame: Day 90
measure: Number of ventilation free days at Day 28
timeFrame: Day 28
measure: Duration of ICU and hospital stay
timeFrame: Day 90
measure: Complications during the ICU stay
timeFrame: Day 90
measure: Dyspnea
timeFrame: Hour 6
measure: Comfort
timeFrame: Hour 6
measure: Level of oxygenation
timeFrame: Hour 48
measure: Organ Failure during the 48 hours after intubation.
timeFrame: Day 28
measure: Duration between the time when prespecified criteria of intubation are met and intubation
timeFrame: Day 28
measure: Duration between treatment initiation and intubation
timeFrame: Day 28
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHu Poitiers
Study officials:
affiliation: CHU Poitiers
name: Jean-Pierre FRAT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613.