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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT06198504
Eligibility Criteria:
Inclusion Criteria:
* Admitted in ICU
* In AHRF, defined as : respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03).
* Indication to intubate based on physician judgment
* Written consent obtained from the patient, relative, or emergency consent.
Exclusion Criteria:
* Contraindications to NIV (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures)
* Severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min to maintain MAP ≥ 65 mmHg) or cardiac arrest
* Do not intubate order
* Pregnancy
* breastfeeding
* Refusal to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06198504
Study Brief:
Protocol Section:
NCT06198504