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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04688450
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (18 years or older) receiving continuous vasopressor infusion to maintain blood pressure;
* Clinician treating patient estimates future duration of vasopressor infusion likely at least 4 additional hours;
* Provider order has been made that sets lower limit for mean arterial pressure;
* Indwelling arterial catheter has been placed for continuous blood pressure monitoring.
Exclusion Criteria:
* Lack of consent or at the discretion of the patient's primary nurse;
* The discretion of any of the patient's other clinical providers;
* People who do not speak English will be excluded. The rationale is that this protocol involves the bedside deployment of an investigational system plus longitudinal observation. Our mitigation for psychosocial risk involves a continual observer who can monitor for any evidence of subject psychosocial discomfort, which involves the ability to effectively communicate with the subject throughout the duration of the protocol. This therefore excludes patients who do not speak English.
* Patients who are on two simultaneous vasopressors running at maximum doses (per the ICUs own protocols) or who is on one maximum-dose vasopressor and has a contraindication to receiving a second vasopressor (e.g., insufficient vascular access).
* Patients who are hypoxic (SpO2 \< 90%) despite maximum inspired oxygen (100% for patients receiving mechanical ventilation, or 10L high-flow in patients who are not candidates for mechanical ventilation).
* Provider order has been made that sets lower limit for SBP (because our system does not have the capability to provide decision-support for an SBP lower limit).
* Enhanced respiratory precautions for COVID.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04688450
Study Brief:
Protocol Section:
NCT04688450