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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06423833
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 18 years old.
* Criteria of high-risk surgical patients:
1. Elderly ≥ 70 years old undergoing major surgery.
2. Physical status ≥ 3 or more undergoing major surgery.
3. Major intraoperative hemorrhage with Surgical Apgar Score (SAS 0-4).
4. Emergency of upper abdominal surgery.
* Criteria of hypoperfusion ≥ 2 or more the following:
1. Mean arterial blood pressure \< 65 mmHg.
2. Urine output \< 0.5 ml/Kg/hr.
3. Capillary refilling time \> 4 seconds.
4. Blood lactate \> 2 mmol/L.
5. ScvO2 \< 70%.
6. CO2 gap \> 6 mmHg.
* Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.
Exclusion Criteria:
* Patients with body mass index \> 35 kg/m2.
* Pregnant female.
* Contraindications to the Trendelenburg position or PLR test (major head trauma, intra-abdominal hypertension and gastric retention).
* Poor echo window or unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable velocity time integral measurements at the left ventricular outflow tract \[LVOT\]).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06423833
Study Brief:
Protocol Section:
NCT06423833