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

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Perioperative Complication; Surgery

Treatments: Device: Near Infrared Spectroscopy (NIRS); Device: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04266574

1211

Details and patient eligibility

About

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.

Full description

Background:

Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion.

Objectives:

This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients.

Design:

BRAIN-PROMISE is a monocentric, randomized controlled trial.

Population:

Hypertensive elderly or frail patients undergoing major surgery.

Experimental Intervention:

Cases will be managed using a NIRS-targeted goal directed therapy.

Control Intervention:

Controls will be managed according to standard care.

Outcomes:

The primary outcome are the incidence of perioperative complications at 30 days and the percentage of successful reversal of reduction in NIRS.

Trial size:

A total of 200 patients will be randomized.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
• presence of an arterial catheter during anesthesia
• planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
• ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations

Exclusion criteria

• Unable to consent to study inclusion
• Language barrier
• Severe neurological or psychiatric disease
• End-stage dementia
• Total Intravenous anesthesia
• No use of hypertensive medication at home.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Near Infrared Spectroscopy (NIRS)

Experimental group

Treatment:

Device: Near Infrared Spectroscopy (NIRS)

Standard Care

Active Comparator group

Treatment:

Device: Standard Care