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Not yet recruitingNCT06759506Updated Mar 17, 2025

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

An observational study in Perfusion Index and Cerebral NIRS Trends in Low Cardiac Output Syndrome, sponsored by Bozyaka Training and Research Hospital. Not yet recruiting. Open to participants aged 1 Day to 6 Years. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Bozyaka Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
1 Day to 6 Years
Sex
All
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Study 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.

Read the detailed description

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.

02

Conditions studied

  • Perfusion Index and Cerebral NIRS Trends in Low Cardiac Output Syndrome

Browse trials for

Keywords

  • Congenital Cardiac Surgery
  • Perfusion Index
  • Low Cardiac Output Syndrome
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In context

Cardiac Output, Low

99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 48 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Bozyaka Training and Research Hospital is the lead sponsor of 51 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
06

What researchers measure

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

  5. Mortality

    Mortality in pediatric cardiac surgery cases with low cardiac output

    Time frame: 24 hours postoperatively

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2025; primary completion for Aug 2025, 4 months later.

Of 22 observational studies under Cardiac Output, Low, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2024
First posted
Jan 6, 2025
StartEst.
Apr 1, 2025
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2025
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06759506
Lead sponsor
Bozyaka Training and Research Hospital
Collaborators
Basaksehir Cam & Sakura City Hospital
Responsible party
Ezgi Direnç YÜCEL (Consultant Anaesthetist, Bozyaka Training and Research Hospital) — Principal investigator
First posted
Jan 6, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Mar 17, 2025

Study contacts

Ezgi Direnç Yücel
Contact
ezgidirenckulunk@yahoo.com
+905073341373 ext. MD
Zeynep Akdağ
Contact
zynpydn33@gmail.com
+95385702695 ext. MD, res
Funda Gümüş Özcan
study director · Istanbul Cam and Sakura City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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