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:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT07131228
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following:
Age ≥ 18 years at the time of enrollment.
Receiving controlled mechanical ventilation with a baseline tidal volume of 6 mL/kg of predicted body weight.
Clinical indication for assessment of fluid responsiveness.
Adequate acoustic window for ultrasound visualization of the portal vein.
Exclusion Criteria:
Participants will be excluded if they have any of the following:
Liver cirrhosis.
Right heart failure, defined as any of the following on prior echocardiography:
Tricuspid annular plane systolic excursion (TAPSE) \< 16 mm
S' wave \< 10 cm/s
Right ventricular fractional area change \< 35%
Left heart failure (left ventricular ejection fraction \< 50%).
Intra-abdominal hypertension.
Atrial fibrillation or other significant cardiac arrhythmias.
Tricuspid regurgitation.
Poor echogenic window preventing adequate ultrasound assessment.
Presence of spontaneous breathing activity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07131228
Study Brief:
Protocol Section:
NCT07131228