Brain-targeted goal-directed therapy in high-risk patients undergoing major elective surgery: Study protocol for the BRAIN-PROMISE randomized trial.
Massimiliano Greco, Giulio Calgaro, Mattia Cavallo...
https://pubmed.ncbi.nlm.nih.gov/40328360Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04266574
BRAIN-targeted Goal-directed Therapy in High-risk Patients Undergoing Major Elective Surgery: the BRAIN-PROMISE Study
Led by Istituto Clinico Humanitas · Updated on 2024-10-23
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Near Infrared Spectroscopy (NIRS) as a monitoring tool to reduce complications after surgery in high-risk patients. The study focuses on elderly or frail patients with hypertension undergoing major elective surgeries. It aims to understand if maintaining brain oxygen levels through NIRS can improve outcomes and reduce surgery-related problems within 30 days after the operation. In this randomized controlled trial, participants are assigned to one of two groups. The experimental group receives NIRS-targeted goal-directed therapy where brain oxygen saturation is continuously monitored during surgery, and adjustments are made if oxygen levels drop. The control group receives standard care with usual monitoring methods, but NIRS data is recorded without guiding treatment. Both groups undergo major surgeries lasting more than an hour under general anesthesia. During the study, participants will have continuous brain oxygen monitoring and hemodynamic assessments during surgery. Researchers will track complications including cognitive issues like delirium up to 30 days post-surgery. Data on blood pressure, anesthesia levels, fluid use, and vasopressor medications will also be collected. The total study enrollment is 200 patients, and monitoring extends through the post-anesthesia care unit and intensive care unit if applicable.
CONDITIONS
Brief Title
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Hypertensive patients with ASA score 2 or higher who are either aged 65 years or older or have a frailty score of 5 or more
- Presence of an arterial catheter during anesthesia
- Planned major surgery (abdominal, vascular, urologic, thoracic with one-lung ventilation) lasting longer than 60 minutes under general anesthesia
- Ability to give informed consent according to regulations
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Duration of surgery and immediate post-anesthesia care
Participants undergo major elective surgery with continuous monitoring of brain oxygen levels (using Near Infrared Spectroscopy) during anesthesia and immediate post-anesthesia care. Hemodynamic optimization is applied if brain oxygen levels drop.
1 surgery and post-anesthesia care visit (in-person)
Post-operative Follow-up
Duration - 30 days
Participants are followed up to assess perioperative complications and recovery outcomes up to 30 days after surgery.
Follow-up visits as per clinical routine
Trial Site Locations
Total: 1 location
1
Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
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Research Team
M
Maurizio Cecconi, Prof, MD
M
Massimiliano Greco, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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