Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT02739451
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02739451
Study Brief:
Protocol Section:
NCT02739451