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Value of the Time-Weighted Average (TWA) of Mean Arterial Pressure (MAP) and Cerebral Oximetry (rSO₂) as Predictors of Postoperative Tissue Perfusion Impairment in Patients Undergoing Cardiac Surgery

NCT07510711 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-04-03

No results posted yet for this study

Summary

Neurological problems after heart surgery are common and include confusion, memory loss, and difficulty thinking clearly. These issues may appear hours or days after surgery and can negatively affect recovery.

During heart surgery, blood flow and oxygen delivery to the brain may decrease, causing changes in blood pressure and cerebral oxygenation. Previous studies suggest that prolonged drops in mean arterial pressure (MAP) or cerebral oxygenation (rSO₂) are linked to worse postoperative outcomes. Continuous monitoring of blood pressure and cerebral oxygenation is standard in cardiac surgery.

This study aims to evaluate the duration and severity of intraoperative drops in MAP and cerebral oxygenation. These measures may provide a more accurate assessment of neurological risk than isolated measurements.

The primary objective is to determine whether decreases in MAP and cerebral oxygenation, as well as their duration and intensity during surgery, are associated with postoperative neurological complications.

This is a prospective, observational study in adult patients undergoing cardiac surgery, with or without cardiopulmonary bypass (CPB). CPB diverts blood through a machine that performs the work of the heart and lungs while the heart is operated on. All patients will receive standard monitoring, including continuous MAP and cerebral oxygenation measurements. No additional interventions will be performed.

Neurological status will be assessed using validated clinical scales before and after surgery. Other outcomes include kidney function, ICU and hospital stay length, postoperative complications, and in-hospital mortality.

Validating these measures as a predictive tool could enable early identification of patients at higher risk of neurological injury and allow more individualized intraoperative management to reduce morbidity, hospital stay, and healthcare costs.

Conditions

  • Delirium - Postoperative
  • Postoperative Cognitive Dysfunction (POCD)
  • Postoperative Acute Kidney Injury
  • Postoperative Morbidity
  • Intensity Care Unit Length of Stay

Interventions

OTHER

Continuous intraoperative monitoring of MAP and rSO₂; observational study with no therapeutic intervention.

Participants will undergo continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂). MAP will be measured invasively via an arterial catheter, and rSO₂ will be assessed non-invasively using near-infrared spectroscopy (NIRS). Monitoring will begin from induction of anesthesia until the end of surgery. No therapeutic interventions will be applied as part of the study; all anesthetic and surgical management will follow standard institutional protocols. The collected MAP and rSO₂ data will be used to calculate time-weighted averages (TWA), which will then be analyzed for associations with postoperative neurocognitive dysfunction (delirium or cognitive impairment) and other clinical outcomes.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-31
Completion
2027-11-30

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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 NCT07510711 on ClinicalTrials.gov