"Hypotension Probability Indicator in TAVI/MitraClip for Hypotension Management"

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 10, 2024

Primary Completion Date

December 10, 2024

Study Completion Date

December 10, 2024

Conditions
Hypotension During SurgeryPrevention of Hypotension
Interventions
DEVICE

Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm

"Hemosphere monitoring and requires the use of a AcumenIQ sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study).~In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart. If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immediately. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension."

Trial Locations (1)

12462

Attikon Hospital, Athens

All Listed Sponsors
lead

Attikon Hospital

OTHER

NCT06347211 - "Hypotension Probability Indicator in TAVI/MitraClip for Hypotension Management" | Biotech Hunter | Biotech Hunter