BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 17, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
SurgeryPerioperative Complication
Interventions
DEVICE

Near Infrared Spectroscopy (NIRS)

"The anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission.~When a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol."

DEVICE

Standard Care

Controls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS.

Trial Locations (1)

20089

RECRUITING

Humanitas Research Hospital, Rozzano

All Listed Sponsors
lead

Istituto Clinico Humanitas

OTHER