Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study
Brief Summary: Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute deterioration of clinical status. Non-invasive ventilation (NIV) is the first option for the clinical management of CF patients with moderate-to-severe respiratory distress and NIV has been shown to improve gas exchange, reduce respiratory muscle work and improve pulmonary function in patients with obstructive lung disease in general and those with acute CF exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides a small positive pressure, probably washes-out the pharyngeal dead space, reduces inspiratory resistance, and possibly facilitates secretion clearance. The technique is very well tolerated. From a physiologic standpoint, this device could help CF patients by improving gas exchange, reducing respiratory workload, and facilitating mucus clearance. Non-interrupted delivery may be possible given better clinical tolerance in contrast with bi-level positive pressure NIV. Whether the short-term physiological efficacy of HFN is comparable to NIV is unknown and there is no study on the benefit of HFN in CF patients.

The aim of this study is to compare the physiological effects of HFN and NIV in CF patients requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease dead space. In addition, comfort and preference between the two techniques will be evaluated.


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 ≥ 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:

* planned pulmonary lobectomy for lung cancer

Exclusion Criteria:

* age \<18 years
* patient refusal
* body mass index ≥35 kg/m2
* sleep apnea syndrome
* tracheostomy
* home oxygen therapy
* pregnancy
D: Inclusion Criteria:

* Patients mechanically ventilated for \> 48 hours and at least one of the following:
* \>65 years
* cardiac failure as the primary indication of mechanical ventilation
* Chronic Obstructive Pulmonary Disease
* Severity score (APACHE II \>12 points) the extubation day
* Body Mass Index \>30
* inability to manage respiratory secretions
* 1 failed spontaneous breathing trial
* 1 comorbidity
* 7 days under mechanical ventilation

Exclusion Criteria:

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

Answer: A