Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Postoperative Complications

Treatments: Other: Correction rSO2 desaturation.; Other: Standard treatment

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02155868

NIRS-in-CS

Details and patient eligibility

About

Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.

Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

High-risk cardiac surgery patients as determined by at least one of the followings:

• the age greater than or equal to 75 years on the day of screening;
• left ventricle ejection fraction less than 35%;
• use of a preoperative intraaortic balloon pump;
• combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)

Exclusion criteria

• refusal of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C. Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it.

Treatment:

Other: Correction rSO2 desaturation.

Control

Placebo Comparator group

Description:

Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.

Treatment:

Other: Standard treatment