Pediatric Surgical PatientsNCT05852899
Evaluation of Preoperative Risk Factors in Children
An observational study of Pediatric Surgical Patients, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Pediatric Surgical Patients
- How many people
- 326 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 4 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Pediatric patients (<18 years) undergoing elective or emergency surgery in the pediatric surgery operating room.
Who cannot join
- Patients admitted to the operating room directly from the intensive care unit.
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tuğba Yeşilyurt Doğu
Istanbul, Istanbul, Fatih, 34098
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Surgical Patients
- Keywords
- ASA Physical Status, pediatric surgery, preoperative risk assessment, perioperative risk, pediatric anesthesia, ICU admission prediction
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 72 hours after surgery
Postoperative PICU admission
Number of participants of Postoperative Pediatric Intensive Care Unit admission
Measured: postoperative follow-up ( in 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jun 2022
- Primary completion1 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical PatientsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tugba yesilyurt dogu, Istanbul University - Cerrahpasa
- Investigators
- Tugba Yesilyurt Dogu, MD, Principal investigator, Istanbul University- Cerrahpaşa (IUC)Pinar Kendigelen, MD, Study director, Istanbul University- Cerrahpaşa (IUC)Ayse Cigdem Tutuncu, MD, Study chair, Istanbul University- Cerrahpaşa (IUC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852899
- Sponsor's protocol ID
- 144674
- Status last verified
- Apr 2026
- First submitted
- 1 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Indıvidual participant data (IPD) sharing plans have not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Risk Factors for ICU Admission in Children
- ClinicalTrials.gov ID
- NCT05852899
- Acronym / sponsor ID
- 144674
- Conditions
- Pediatric Surgical Patients
- Keywords
- ASA Physical Status, pediatric surgery, preoperative risk assessment, perioperative risk, pediatric anesthesia, ICU admission prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Pediatric patients (<18 years) undergoing elective or emergency surgery in the pediatric surgery operating room.
Key exclusion criteria (2 listed)
- Patients admitted to the operating room directly from the intensive care unit.
- Patients with incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Postoperative PICU admission
Time frame: postoperative follow-up ( in 72 hours)
Number of participants of Postoperative Pediatric Intensive Care Unit admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided. Indıvidual participant data (IPD) sharing plans have not yet been determined.
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Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
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The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tugba Yesilyurt Dogu, MD principal investigator
Istanbul University- Cerrahpaşa (IUC)
Pinar Kendigelen, MD study director
Istanbul University- Cerrahpaşa (IUC)
Ayse Cigdem Tutuncu, MD study chair
Istanbul University- Cerrahpaşa (IUC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Surgical Patients, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pediatric Intensive Care Unit (PİCU) Admission (time frame: Within 72 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.