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

NCT04266574 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-23

No results posted yet for this study

Summary

The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.

Conditions

  • Surgery
  • Perioperative 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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Maurizio Cecconi, Prof, MD · Humanitas Research Hospital IRCCS, Rozzano-Milan

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266574 on ClinicalTrials.gov