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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT01925534
Eligibility Criteria:
Inclusion Criteria:
* Patients of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.
* Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH \<7.35 and arterial CO2 \> 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or
* Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio \< 300 and respiratory rate ≥ 24.
* Anticipated duration on NIV of at least 24 hrs
Exclusion criteria:
* Usual contraindications to NIV
* Respiratory arrest
* Unable to fit mask
* Medically unstable or multiple organ failure or unstable coronary disease
* Agitated or uncooperative
* Unable to protect airways
* Swallowing difficulties
* Excessive secretions not managed by clearance techniques
* Recent upper airway or gastro-intestinal surgery
* Facial deformity or previous head and neck surgery
* Undrained pneumothorax
* NIV failure within first 2 hours (either intolerance or requirement for intubation)
* Managed for greater than 48 hours on NIV prior to randomization
* Disorientation, confusion, unable to rate comfort or dyspnea
* Expected to require NIV for fewer than 24 hrs from the time of enrollment
* Patient previously in study
* Patients on CPAP nighttime only due to OSA
Withdrawal/Termination criteria:
* Patients will be withdrawn from the study when NIV fails and/or the patient is intubated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01925534
Study Brief:
Protocol Section:
NCT01925534