"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management (NCT06347211) | Clinical Trial Compass
CompletedNot Applicable
"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management
Greece100 participantsStarted 2024-01-10
Plain-language summary
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Will be monitored intraoperatively for \>1 hour or will receive general anesthesia for \>1 hour
* Will undergo intraoperative monitoring with invasive arterial pressure measurement
* Mean arterial pressure (MAP) target will be ≥ 65 mmHg intraoperatively
* Will sign written informed consent preoperatively
* Will undergo TAVI or Mitral Clip under general anesthesia or monitored anesthesia care (MAC) and sedation
* American Society of Anesthesiologists (ASA) Physical Status ≤ 4
Exclusion Criteria:
* Target for MAP different from 65 mmHg
* Severe hypotension preoperatively MAP \<65 mmHg
* Severe heart failure (e.g., Left Ventricular Ejection Fraction\<20%)
* Patients needing or will need mechanical circulatory support postoperatively (e.g., intra-aortic pump)
* Urgent surgery
* Patients with severe pulmonary hypertension (preexisting or detected intraoperatively)
* Patients with hemodynamic instability requiring extracorporeal circulation support
What they're measuring
1
TWA hypotension (measured with Acumen IQ sensor)
Timeframe: Intraoperatively,10 min after induction of anesthesia or commencement of sedation