NCT02155868

Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postoperative Complications

Interventions

Type	Name	Description
OTHER	Correction rSO2 desaturation.	Predefined protocol of interventions for correcting rSO2 desaturation (\< 60%) during cardiac surgery and the first six hours after it. In case of rSO2 decrease less than 60% correct: head position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood \< 35 mmHg; mean arterial pressure \< 60 mmHg; central venous pressure \> 10 mmHg; cardiac index \< 2.0 l/min/m2; mixed venous oxygen saturation \< 60%; hemoglobin \< 65 g/L during cardiopulmonary bypass or hemoglobin \< 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption.
OTHER	Standard treatment	Standard treatment

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-06-04
• Last updated: 2017-01-26

Locations

1 site across 1 country: Russia