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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04711759
Eligibility Criteria:
Inclusion Criteria:
* Mechanical ventilation (MV) through an orotracheal tube for at least 48 hours
* PaO2 /FiO2 ratio ≤ 300 mmHg
* Potential for weaning as determined in routine daily screening (precipitating cause leading to MV in resolution, adequate oxygenation (PaO2/FiO2 ≥150 mmHg with FiO2 ≤0.4 and PEEP ≤8 cm H2O), arterial pH \>7.25, hemodynamic stability (no vasopressors or Noradrenaline ≤0.1 mcg/kg/min), temperature \<38°C, presence of inspiratory effort and appropriate spontaneous cough, and the patient is not receiving sedatives and is awake and able to follow simple commands)
* Decision to perform a spontaneous breathing trial by the attending physician
Exclusion Criteria:
* Patients ventilated for decompensated chronic obstructive pulmonary disease
* Contraindications to HFNC, which include abnormalities or surgery of the face, nose, or airway that preclude an appropriate-fitting nasal cannula.
* Contraindications for esophageal balloon catheter insertion (eg. severe coagulopathy, esophageal varices, and history of esophageal or gastric surgery)
* Contraindication for use of electric impedance tomography (eg. Pacemaker)
* Presence of tracheostomy
* Refusal to participate by the attending physician
* Do not resuscitate order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04711759
Study Brief:
Protocol Section:
NCT04711759