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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Undergoing cardiac surgery, with or without cardiopulmonary bypass

Written informed consent

Preoperative cognitive status: Glasgow Coma Scale score of 15; no history of dementia; no evidence of cognitive impairment on baseline assessment; patient oriented and cooperative prior to surgery

Disqualifiers

History of dementia or cognitive impairment

Emergency surgeries

Trial population

Adult patients (≥18 years) undergoing cardiac surgery, with or without cardiopulmonary bypass. Patients must provide written informed consent, have a preoperative Glasgow Coma Scale score of 15, no history of dementia or cognitive impairment, and be oriented and cooperative prior to surgery. Continuous intraoperative monitoring of mean arterial pressure (MAP) and cerebral regional oxygen saturation (rSO₂) is performed. Emergency surgeries and patients with pre-existing cognitive impairment are excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Adult patients undergoing cardiac surgery1 intervention

Trial outcomes

Primary outcomes

1

Association of TWA-MAP and TWA-rSO₂ with Postoperative Neurocognitive Dysfunction

Postoperative neurocognitive dysfunction (delirium or cognitive impairment) following cardiac surgery

Time frame
From day of surgery until 3 months after surgery

Secondary outcomes

1

Association of TWA-MAP and TWA-rSO₂ with Acute Kidney Injury

acute kidney injury

Time frame
From day of surgery until 3 months after surgery
2

To determine whether TWA-MAP and TWA-rSO₂ are associated with longer intensive care unit (ICU) length of stay.

intensive care unit (ICU) length of stay

Time frame
From day of surgery until 3 months after surgery
3

To determine whether TWA-MAP and TWA-rSO₂ are associated with hospital length of stay

hospital length of stay

Time frame
From day of surgery until 3 months after surgery
4

To determine whether TWA-MAP and TWA-rSO₂ are associated with in-hospital mortality

in-hospital mortality

Time frame
From day of surgery until 3 months after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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