Acute Respiratory Failure
Conditions
Keywords
High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit
Brief summary
The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.
Detailed description
This randomized controlled trial is a superiority study to test if one of the methods (NIV and/or HFNO) is superior to standard oxygen in ARF patients requiring oxygen. It is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).
Interventions
PROCEDUREStandard oxygen
Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
PROCEDUREHFNO
The oxygen therapy will be administered in a semi-sitting position, with a setting of the FiO2 and the oxygen flow rate, to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
PROCEDURENIV
Systematic application of NIV using two levels of pressure, pressure support (PS) + positive end-expiratory pressure (PEEP) provided using a dedicated NIV ventilator or a standard ICU ventilator with the NIV module through a facial mask. The FiO2 will be set to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age ≥ 18 years) * A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure \<60 mm Hg when breathing room air or \<80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation \[SpO2\] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio \< 300 mmHg plus either \[1\] a respiratory rate higher than 30/min or \[2\] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction).
Exclusion criteria
* Contraindications to NIV and/or HFNO * Sleep apnea syndrome with home ventilator * Immediate tracheal intubation * Requirement for an emergent surgical procedure requiring intubation * Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia) * Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included. * Anatomical factors precluding the use of NIV and/or HFNO * Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order * Pregnancy in progress or planned during the study period or breastfeeding women * Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship * Subjects not covered by public health insurance * Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day-28 mortality | Up to Day-28 | Mortality rates at Day-28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation rate at Day-28 | Day-28 | Proportion of patients requiring invasive mechanical ventilation |
| Intubation rate at Day-3 | Day-3 | Proportion of patients requiring invasive mechanical ventilation |
| Intubation rate at Day-7 | Day-7 | Proportion of patients requiring invasive mechanical ventilation |
| Oxygenation up to Day-7 | Up to Day-7 | Proportion of patients with better oxygenation |
| Need of other rescue oxygen therapy up to Day-7 | Up to Day-7 | Proportion of patients requiring rescue oxygen therapy |
| Adverse events | Up to Day-90 | Related to the treatment |
| Hospital length of stay | Up to Day-90 | Duration time in Hospital |
| Mortality rates in ICU | Up to Day-90 | Mortality rates in ICU |
| Mortality rates in hospital | Up to Day-90 | Mortality rates in hospital |
| Day-90 mortality | Day-90 | Mortality rates at Day-90 |
| ICU length of stay | Up to Day-90 | Duration time in ICU |
Countries
France
Contacts
Primary ContactSamir Jaber, MD, PhD
Backup ContactAudrey DE JONG, MD,PhD
Outcome results
None listed