NCT05852899

Brief Summary

This study aimed to evaluate preoperative risk factors in pediatric patients and to determine their effectiveness in predicting intensive care unit admission within 72 hours. The study also aimed to better define the pediatric population and identify factors associated with perioperative risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

May 1, 2023

Last Update Submit

April 17, 2026

Conditions

Pediatric Surgical Patients

Keywords

ASA Physical Statuspediatric surgerypreoperative risk assessmentperioperative riskpediatric anesthesiaICU admission prediction

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pediatric Intensive Care Unit (PİCU) Admission

    Number of participants requiring admission to the pediatric intensive care unit (PICU) within 72 hours after surgery. PICU admission was recorded as a binary outcome (yes/no).

    Within 72 hours after surgery

  • Postoperative PICU admission

    Number of participants of Postoperative Pediatric Intensive Care Unit admission

    postoperative follow-up ( in 72 hours)

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients (\<18 years) undergoing elective or emergency surgery in the pediatric surgery operating room at Cerrahpasa Medical Faculty. Patients were evaluated preoperatively and followed for postoperative intensive care unit (PICU) admission.

You may qualify if:

  • Pediatric patients (\<18 years) undergoing elective or emergency surgery in the pediatric surgery operating room.

You may not qualify if:

  • Patients admitted to the operating room directly from the intensive care unit.
  • Patients with incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Yeşilyurt Doğu

Istanbul, Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Study Officials

  • Tugba Yesilyurt Dogu, MD

    Istanbul University- Cerrahpaşa (IUC)

    PRINCIPAL INVESTIGATOR

  • Pinar Kendigelen, MD

    Istanbul University- Cerrahpaşa (IUC)

    STUDY DIRECTOR

  • Ayse Cigdem Tutuncu, MD

    Istanbul University- Cerrahpaşa (IUC)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 4, 2023

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

TU(1)