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NCT Number: NCT06759506

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

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.

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Key information

About this study

All patients will have their demographic characteristics routinely recorded, including preoperative echocardiographic measurements and initial hemodynamic monitoring parameters before surgery. Operative details such as operation and anesthesia durations, bypass and cross-clamp times, heart rate, blood pressure, NIRS values, urine output, blood gas parameters, and use of inotropes and blood products will also be documented.

During the first 24 hours postoperatively, at 0, 6, 12, and 24 hours, bedside visits will be conducted to record the following parameters per patient: heart rate, blood pressure, urine output, peripheral and central body temperature, capillary refill time, inotropic requirement, blood product requirement, serum lactate level, central venous oxygen saturation, cerebral Near-Infrared Reflectance Spectroscopy, and Perfusion Index (PI) values.

Preoperative and perioperative parameters will be recorded by anesthesia technicians and anesthesiologists; postoperative parameters will be recorded by Pediatric Cardiac Intensive Care physicians and nurses. The monitoring methods and parameters followed in the research are routine in pediatric cardiac surgery during intraoperative and postoperative periods.

Echocardiographic findings immediately post-operation and within the first 24 hours will be noted to observe the presence and severity of Low Cardiac Output Syndrome.

With these recorded parameters, the presence of Low Cardiac Output Syndrome within the first 24 hours postoperatively will be examined, alongside the assessment of inotropic requirement, need for dialysis, use of extracorporeal membrane oxygenation, revision surgeries, mortality, and morbidity. This data will be used to investigate the frequency of Low Cardiac Output Syndrome, its causes, and the relationship with NIRS and PI in pediatric patients aged 0-6 undergoing congenital cardiac surgery.

The monitoring methods and parameters followed in the research are routine in pediatric cardiac surgery during intraoperative and postoperative periods. They do not require additional costs or manpower. The researchers will conduct the study in accordance with the Helsinki Declaration and Good Clinical Practice principles.

Every patient, whether enrolled in any study or not, will be routinely monitored by our team during anesthesia administration and post-anesthesia care (this monitoring practice includes regular visits, examinations, and follow-ups of our clinic's patients). Consent will be obtained from our patients for these practices, and no additional laboratory tests will be conducted for this study. Patients will receive their routine treatments as needed without any alterations. In this study, intraoperative and postoperative monitoring data that have been observed will be used.

Since no additional interventions beyond our routine practices will be undertaken, no circumstances threatening patient safety, problems, or complications are expected to arise At the conclusion of the study, all data will be entered into a computer and analyzed using the SPSS software. Statistical methods including chi-square test, student's t-test, and Mann-Whitney U test will be used for intergroup comparisons, with a significance level set at P ≤ 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. PI in low cardiac output

    Time frame: 24 hours postoperatively

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

  2. Serebral NIRS in low cardiac output

    Time frame: Intraoperatively and first 24 hours postoperatively

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

Secondary outcomes

  1. Inotropic requirements

    Time frame: Intraoperatively and first 24 hours postoperatively

    Inotropic requirements in pediatric cardiac surgery cases with low cardiac output

  2. Need for dialysis

    Time frame: 24 hours postoperatively

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

  3. Need for ECMO (extracorporeal membrane oxygenation)

    Time frame: 24 hours postoperatively

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

  4. Need for reoperation

    Time frame: 24 hours postoperatively

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

  5. Mortality

    Time frame: 24 hours postoperatively

    Mortality in pediatric cardiac surgery cases with low cardiac output

Study contacts

Contact information is provided by the study sponsor or research team.

Ezgi Direnç Yücel

CONTACT

[email protected]

+905073341373 ext. MD

Zeynep Akdağ

CONTACT

[email protected]

+95385702695 ext. MD, res

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Collaborators

  • Basaksehir Cam & Sakura City Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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