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Can Perfusion Index and Cerebral Oxygen Saturation Trends Predict Low Cardiac Output in Pediatric Cardiovascular Surgeries

ConditionPerfusion Index and Cerebral NIRS Trends in Low Cardiac Output Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorBozyaka Training and Research Hospital

About this trial

In this prospective, observational study, we aim to investigate whether routinely monitored Perfusion Index (PI) and cerebral oxygen saturation (NIRS) values in pediatric patients aged 0-6 undergoing congenital heart surgery are associated with Low Cardiac Output Syndrome. Pediatric patients aged 0-6 years undergoing congenital heart surgery will be followed primarily for Cerebral Near-Infrared Reflectance Spectroscopy, and Perfusion Index (PI) values both in the operating room during the operation, and in the Pediatric Cardiac Intensive Care Unit during the first 24 hours postoperatively. The patients with Low Cardiac Output Syndrome will be recorded, and the changes in Cerebral Near-Infrared Reflectance Spectroscopy, and Perfusion Index (PI) values will be evaluated to determine whether they can predict low cardiac output.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 0-6 years who undergo congenital heart surgery and develop low cardiac output syndrome

Disqualifiers

Patients older than 6 years

Premature infants

Patients who were operated on at external institutions and later transferred to our facility

Patients with low cardiac output syndrome not related to the postoperative period

Trial population

Patients aged 0-6 years who undergo congenital heart surgery and develop low cardiac output syndrome

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

PI in low cardiac output

Perfusion Index (PI) trends in pediatric cardiac surgery cases with low cardiac output

Time frame
24 hours postoperatively
2

Serebral NIRS in low cardiac output

Serebral NIRS in trends in pediatric cardiac surgery cases with low cardiac output

Time frame
Intraoperatively and first 24 hours postoperatively

Secondary outcomes

1

Inotropic requirements

Inotropic requirements in pediatric cardiac surgery cases with low cardiac output

Time frame
Intraoperatively and first 24 hours postoperatively
2

Need for dialysis

Need for dialysis in pediatric cardiac surgery cases with low cardiac output

Time frame
24 hours postoperatively
3

Need for ECMO (extracorporeal membrane oxygenation)

Need for ECMO in pediatric cardiac surgery cases with low cardiac output

Time frame
24 hours postoperatively
4

Need for reoperation

Need for reoperation in pediatric cardiac surgery cases with low cardiac output

Time frame
24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bozyaka Training and Research Hospital

Lead sponsor

Basaksehir Cam & Sakura City Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: