Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Brief Summary: The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.


Options:
A: Inclusion Criteria:

* Known immunosuppression defined as one or more of the following: (a) immunosuppressive drug or long-term \[\>3 months\] or high-dose \[\>0.5 mg/kg/day\] steroids; (b) solid organ transplantation; (c) solid tumour; (d) haematological malignancy.
* ICU admission for any reason
* Need for oxygen therapy ≥6 Liters/min defined as one or more of the following: (a) respiratory distress with a respiratory rate \>30/min; (b) cyanosis; (c) laboured breathing; (d) SpO2\<90%; and (e) expected respiratory deterioration during a procedure
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Patient admitted to the ICU for end-of-life care. Do-not-intubate (DNI) patients can be included.
* Refusal of study participation or to pursue the study by the patient
* Hypercapnia with a formal indication for NIV \[PaCO2 ≥ 50 mmHg, formal indication for NIV\]
* Isolated cardiogenic pulmonary oedema \[formal indication for NIV\]. Patients with pulmonary oedema associated with another ARF etiology can be included.
* Pregnancy or breastfeeding
* Anatomical factors precluding the use of a nasal cannula
* Absence of coverage by the French statutory healthcare insurance system
* Post surgical setting from D1 to D6

After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, as all included patients need to have an acute hypoxemic respiratory failure and at least 6l of oxygen per minute, patients admitted to the ICU to secure any procedure (bronchoscopy etc..) or those not admitted for acute respiratory failure and who undergo intubation, will NOT be included in this trial. Only patients meeting criteria of acute respiratory failure will be included in this trial.
B: Inclusion Criteria:

* Age ≥ 18
* Admission to ICU for acute respiratory failure defined by all of the following criteria:

  * Dyspnea at rest with RR ≥ 25 breaths/min
  * PaCO2 ≤ 50 mm Hg
  * PaO2/FiO2 ≤ 300 mm Hg under oxygen ≥ 10 l/min through a mask or HFNC or NIV (for patients under oxygen FiO2 will be calculated using the following formula: oxygen flow in liters per minute x 3 + 21)
* Immunosuppresion defined by 1 of the following criteria:

  * Hematological malignancy (active or remitting \< 5 years)
  * Allogenic stem cell transplantation \< 5 years
  * Solid cancer (active)
  * Leucopenia \< 1 G/l or neutropenia ≤ 0.5 G/l after chemotherapy
  * Solid organ transplantation
  * AIDS (not only HIV)
  * Treatment with immunosuppressive or immunomodulatory drugs
  * Systemic steroids ≥ 0.5 mg/kg/d of prednisone-equivalent for ≥ 3 weeks
* Non opposition to participate obtained from the patient or their legally acceptable representative.

Exclusion Criteria:

* Contraindication of NIV (patient refusal, cardiac arrest, coma, not drained pneumothorax, unresolving vomiting, upper airways obstruction, hematemesis, severe facial trauma)
* Chronic respiratory failure with altered pulmonary function tests
* Overt cardiogenic pulmonary edema
* Urgent need for intubation
* Severe shock (vasopressors \> 0.3 µg/kg/min to maintain SAP \> 90 mm Hg)
* Impaired consciousness (Glasgow coma scale score ≤ 12) or agitation
* Surgery under general anesthesia \< 7 days
* Previously included in the trial
* Do-not-intubate order
* Pregnancy or breastfeeding
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection
C: Inclusion Criteria:

* Low Risk Patients:
* Any extubated patients after tolerating a spontaneous breathing trial.
* High Risk Patients:
* Any extubated patients after \>48 hours under mechanical ventilation and any of the following:
* \>65 years

  * cardiac failure as the primary indication of mechanical ventilation
  * COPD
  * APACHE II \>12 points the extubation day
  * BMI \>30
  * inability to manage respiratory secretions

    * 1 failed spontaneous breathing trial
    * 1 comorbidity
    * 7 days under mechanical ventilation

Exclusion Criteria:

* \<18 years
* thacheotomized patients
* recent facial or cervical trauma/surgery
* active gastro-intestinal bleeding
* lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.
D: Inclusion Criteria:

* Mechanical ventilation \> 24h
* Successful spontaneous breathing trial conducted for a period of 30-120 min.
* PaO2/FiO2 ≤ 300 at the end of the spontaneous breathing trial preceding extubation

Exclusion Criteria:

* age\<18 years
* pregnancy
* tracheostomy
* need of NIV post-extubation (prophylactic NIV)

Answer: C