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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT06114992
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent by the patient's legally designated representative(s) (may be obtained as deferred consent up to 24 hours after HFOV initiation: valid for both elective and rescue HFOV patients)
* Patients eligible for HFOV ventilation with Servo-n:
* Patient is either switched from conventional mechanical ventilation or HFOV with other device to Servo-n HFOV based on clinicians judgement (rescue HFOV). Note: the reason for the switch has to be that the patient failed to oxygenate or ventilate adequately with CMV or the other HFOV device
; OR
* Patient was prior without or with any type of non-invasive respiratory support and is put on invasive HFOV treatment based on clinicians judgement (elective HFOV)
* Patient has not already been on HFOV in a previous episode, unless the etiology of respiratory failure has changed during the same hospitalisation. For example, initial HFOV treatment for RDS, second HFOV episode of NARDS of any etiology (will be enrolled as a new patient case). NOTE1: When a patient failed weaning on conventional ventilation within 6 hours, requiring to be put back on HFOV it will be counted as one HFOV episode (weaning failure) NOTE2: When a patient is temporarily put on conventional ventilation for transport or a surgical intervention, and will be put back to HFOV afterwards, it will be counted as one HFOV episode (HFOV paused).
* Patient has a body weight from 0.3 to 8.0 kg
Exclusion Criteria:
* Diagnosis of congenital diaphragmatic hernia
* Severe cardiac anomaly expected to need corrective surgery or catheter-based intervention within 30 days from birth
* Cyanotic heart disease
* Intracranial hemorrhage, Grade III or IV
* Congenital malformations with the exception of isolated lung hypoplasia
* Persistent pulmonary hypertension (PPHN) with a documented shunt on the level of the foramen ovale
* Bronchopulmonary Dysplasia (BPD) /Chronic Lung Disease (CLD)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06114992
Study Brief:
Protocol Section:
NCT06114992