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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05316532
Eligibility Criteria:
Inclusion Criteria:
* Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT\<4 mL/kg, Ppeak \<30 mbar, Driving Pressure ≤12 mbar)
* OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)
* AND Informed Consent as documented by signature
Exclusion Criteria:
* Mechanical Ventilation group: Need for v-v ECMO
* Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated
* Thrombocytopenia (\<100G/l)
* Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)
* Patients under 18 years of age
* Women who are pregnant or breast feeding
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05316532
Study Brief:
Protocol Section:
NCT05316532