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

Complex Congenital Heart Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810013
• Other study ID #: CAR_FN_01
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• term (37-42 weeks gestation) newborns

• pre- or postnatally diagnosed critical congenital heard disease (CHD)

• admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen

Exclusion Criteria:

• birth weight <2 kg

• history of neonatal depression (5-min APGAR<5, cord blood pH<7.0, sepsis, or birth asphyxia)

• perinatal seizures

• evidence of end-organ injury

• preoperative cardiac arrest

• significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.

Related Conditions & MeSH terms

• Complex Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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).

Locations

Country	Name	City	State
Germany	Univeristy Children's Hospital	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of mean arterial blood pressure	Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)	4within 8 hours after cardiac surgery at the PICU
Secondary	Detection of severe brain injury	Detection of cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) on routinely performed serial cranial ultrasound scans	before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge
Secondary	Neurological outcome measure	Landmarks of development score (Grenzsteine der Entwicklung Score) aus (Monatsschr Kinderheilkd_2013 · 161:898-910_· DOI 10.1007/s00112-012-2751-0 © Springer-Verlag Berlin Heidelberg 2013 R._Michaelis_· R._Berger_· U._Nennstiel-Ratzel_· I._Krägeloh-Mann Validierte und teilvalidierte Grenzsteine der Entwicklung).; The score uses dichotomous questions, that asks for a Yes/No response. The score consists of a total of 16 questions, the more questions answered yes, the better the outcome and vice versa. Minimum value is n=0 yes and n=16 no answers, maximum value is n=16 yes and n=0 no answers.	at age of 2 years
Secondary	Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation	Analysis of the influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation.Association between cFTOE and cerebral autoregulation indices (COx and HVx).	within 8 hours after cardiac surgery at the PICU
Secondary	Influence of changed arterial blood pressure on cerebral autoregulation	Analysis of the influence of changed arterial blood pressure on cerebral autoregulation. Association between arterial blood pressure (mmHg) and cerebral autoregulation indices (COx and HVx).	within 8 hours after cardiac surgery at the PICU
Secondary	Influence of changed arterial oxygen saturation on cerebral autoregulation	Analysis of the influence of changed arterial oxygen saturation on cerebral autoregulation. Association between arterial SPO2 (%) and cerebral autoregulation indices (COx and HVx).	within 8 hours after cardiac surgery at the PICU
Secondary	Influence of changed blood hemoglobin concentration on cerebral autoregulation	4. Analysis of the influence of changed blood hemoglobin concentration on cerebral autoregulation. Association between arterial hemoglobin value (g/dL) and cerebral autoregulation indices (COx and HVx).	within 8 hours after cardiac surgery at the PICU