Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients
Brief Summary: Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask \[with or without a bag and with or without the Venturi system\] to achieve SpO2≥95%.

Oxygen therapy may be combined with non-invasive ventilation \[NIV\] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion \[NIV\] was not superior over oxygen without NIV.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality


Options:
A: Inclusion criteria:

* Age ≥ 18 years
* Cystic fibrosis as defined by clinical features in conjunction with 2 CF causing mutations and/or 2 sweat tests with sweat chloride \> 60 mmol/l
* Clinical indication for NIV based on at least one of the following criteria:

  * Signs of clinical respiratory distress - RR \> 24/min, accessory muscle use, or increased dyspnea
  * Progressive increase in arterial PCO2
  * Nocturnal hypoventilation treated by NIV but requiring daytime NIV because of clinical worsening

Exclusion criteria:

* Active massive hemoptysis
* Pneumothorax with pleural drainage and persistent air leak
* Hemodynamic instability requiring vasopressors
* Uncooperative
* Recent upper airway or esophageal surgery
* Patients with skin or chest wall or abdominal trauma
B: Inclusion Criteria:

* Age \>20 years
* Subjective dyspnea in room air
* SaO2\< 90% in room air
* Oxygen requirement for nasal cannula \< 6 L/m

Exclusion Criteria:

* Unstable vital signs

  * SBP \<90 mmHg
  * DBP \< 60 mmHg
  * Heart rate \> 120 bpm
  * Respiratory rate \> 30 bpm
  * Persistent dyspnea under oxygen therapy using NC
* Severe hypoxia

  * PaO2/FiO2\< 200 mmHg
* Unable to cooperate

  * Delirium
  * Reduced cognitive function
C: Inclusion Criteria:

* Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;
* 7.25 \< pH \< 7.35;
* Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;
* Age \> 18 years/old

Exclusion Criteria:

* Invasive mechanical ventilation in the last 60 days
* Use of any form of noninvasive ventilation or high flow oxygen through nasal cannula (HFNT) prior to study enrollment after the onset of acute hypercapnic respiratory failure (AHRF);
* Noninvasive home care ventilation;
* Unstable clinical condition (need for vasopressors for \>24 h, acute coronary syndrome or life-threatening arrhythmias);
* Refusal of treatment;
* Agitation (RASS \>= +2) or non-cooperation (Kelly Matthay \>=5);
* Failure of more than two organs;
* Cardiac arrest;
* Respiratory arrest requiring tracheal intubation;
* Recent trauma or burns of the neck and face;
* Pregnancy;
* Refusal of consent;
* Inclusion in other research protocols.
D: 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.

Answer: D