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

NCT06759506 | Not Yet Recruiting

• 1 other identifier: ZeynepTez
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perfusion Index and Cerebral NIRS Trends in Low Cardiac Output Syndrome

Keywords

Congenital Cardiac Surgery; Perfusion Index; Low Cardiac Output Syndrome

Outcome Measures

Primary Outcomes (2)

• PI in low cardiac output

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

  24 hours postoperatively

• Serebral NIRS in low cardiac output

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

  Intraoperatively and first 24 hours postoperatively

Secondary Outcomes (5)

• Inotropic requirements

  Intraoperatively and first 24 hours postoperatively

• Need for dialysis

  24 hours postoperatively

• Need for ECMO (extracorporeal membrane oxygenation)

  24 hours postoperatively

• Need for reoperation

  24 hours postoperatively

• Mortality

  24 hours postoperatively

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead
• Basaksehir Cam & Sakura City Hospital: collaborator

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Funda Gümüş Özcan

  Istanbul Cam and Sakura City Hospital

  STUDY DIRECTOR

Central Study Contacts

Ezgi Direnç Yücel

CONTACT

+905073341373; ezgidirenckulunk@yahoo.com

Zeynep Akdağ

CONTACT

+95385702695; zynpydn33@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share