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Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

NCT04766554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-01-28

No results posted yet for this study

Summary

Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

Conditions

  • Cardiac Disease
  • Cognitive Dysfunction

Interventions

DEVICE

Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions

In the intervention group, an alarm threshold below 15% of the baseline rSO2 value will be established. Based on the predetermined algorithm the rSO2 will be maintained at or above 85% of the baseline measurements. If the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed to restore rSO2 to baseline levels.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia de Laranjeiras

    lead OTHER

Principal Investigators

  • Carlos Galhardo, MD · Instituto Nacional de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-08-20
Completion
2024-08-20

Countries

  • Brazil

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 NCT04766554 on ClinicalTrials.gov