NCT04810013

Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease

Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply

Detailed description

Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period. Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation. Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.

Conditions

• Complex Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	non-invasive measurement of cerebral autoregulation	Non-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise).

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-12-31
• Completion: 2023-11-30
• First posted: 2021-03-22
• Last updated: 2023-12-21

Locations

1 site across 1 country: Germany