- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852899
Evaluation of Preoperative Risk Factors in Children
April 17, 2026 updated by: tugba yesilyurt dogu, Istanbul University - Cerrahpasa
Preoperative Risk Factors for ICU Admission in Children
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study was to evaluate preoperative risk factors and determine their effectiveness in predicting ICU admission after emergency or elective surgery in pediatric patients .
To achieve this aim, data such as gender, age, height, weight, history of prematurity, post-conceptional week, ASA physical status (ASA-PS), comorbidites, history of previous anesthesia, type of surgery, tumor surgery, chemotherapy and radiotherapy history, surgical risk classification, and difficult airway were recorded.
Study Type
Observational
Enrollment (Actual)
326
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul, Fatih
-
Istanbul, Istanbul, Fatih, Turkey (Türkiye), 34098
- Tuğba Yeşilyurt Doğu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Pediatric patients (<18 years) undergoing elective or emergency surgery in the pediatric surgery operating room.
Exclusion Criteria:
- Patients admitted to the operating room directly from the intensive care unit.
- Patients with incomplete clinical data.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative PICU admission
Time Frame: postoperative follow-up ( in 72 hours)
|
Number of participants of Postoperative Pediatric Intensive Care Unit admission
|
postoperative follow-up ( in 72 hours)
|
|
Postoperative Pediatric Intensive Care Unit (PİCU) Admission
Time Frame: Within 72 hours after surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tugba Yesilyurt Dogu, MD, Istanbul University- Cerrahpaşa (IUC)
- Study Director: Pinar Kendigelen, MD, Istanbul University- Cerrahpaşa (IUC)
- Study Chair: Ayse Cigdem Tutuncu, MD, Istanbul University- Cerrahpaşa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 4, 2023
Study Registration Dates
First Submitted
May 1, 2023
First Submitted That Met QC Criteria
May 1, 2023
First Posted (Actual)
May 10, 2023
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 144674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Indıvidual participant data (IPD) sharing plans have not yet been determined.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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