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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02048566
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older AND
* Mechanical ventilation AND
* Systemic mean blood pressure \< 60 mmHg (or \< 80 mmHg if the patient has baseline hypertension) for more than 30 minutes despite adequate fluid resuscitation (minimum of 20 ml/kg crystalloids) OR
* Maintaining the systemic mean blood pressure \> 60 mmHg requires any dose of vasopressors or inotropes AND at least one of the following:
* Capillary refilling time three seconds or longer
* Lactate \>2 mmol/L
* Urine output \<0.5 mL/kg for at least one hour
* Written informed consent
Exclusion Criteria
* Unrepaired tracheoesophageal fistula
* History of prior esophageal or gastric surgery precluding the use of TEE
* Esophageal obstruction or stricture
* Esophageal varices or diverticulum
* Esophageal or gastric perforation
* Gastric or esophageal bleeding
* Vascular ring, aortic arch anomaly with or without airway compromise
* Recent oropharyngeal surgery
* Severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or INR \> 3)
* Cervical spine injury or anomaly
* Elective ICU admission after elective surgery
* Use of cardiac assist devices
* Use of extra-corporeal membrane oxygenation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02048566
Study Brief:
Protocol Section:
NCT02048566