Evaluation of Preoperative Risk Factors in Children

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT05852899
Collaborator
(none)
300
1
7.1
42.1

Study Details

Study Description

Brief Summary

  1. The investigators aimed to make a more advanced risk assessment in predicting preoperative intensive care unit admission in pediatric patients.

  2. The investigators aimed to better define the pediatric patient population and identify preoperative risk factors in detail in order to reduce perioperative complications.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study was to evaluate preoperative risk factors and determine their efficacy in predicting ICU admission after emergency or elective surgery in pediatric patients of all age groups. To achieve this aim, data such as gender, age, height, weight, history of prematurity, post-conceptional week, ASA PS score, accompanying systemic diseases, history of previous anesthesia, history of emergency or elective surgery, tumor surgery, chemotherapy and radiotherapy, surgical risk classification, difficult airway will be collected.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Preoperative Risk Factors in Prediction of ICU Admission in Children, An Observational Prospective Study
    Actual Study Start Date :
    Jun 1, 2022
    Actual Primary Completion Date :
    Jan 1, 2023
    Actual Study Completion Date :
    Jan 4, 2023

    Outcome Measures

    Primary Outcome Measures

    1. ASA-PS [Preoperative visit period ( 20 minutes)]

      The American Society of Anesthesiologists (ASA) physical status preoperative risk assesttment

    2. Postoperative PICU admission [postoperative follow-up ( in 72 hours)]

      Number of participants of Postoperative Pediatric Intensive Care Unit admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children under the age of 18 who will have an operation in the pediatric surgery operating room.
    Exclusion Criteria:
    • Children who are scheduled for surgery in pediatric surgery room but are hospitalized in the intensive care unit.(Children admitted directly from the intensive care units to the operating rooms)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tuğba Yeşilyurt Doğu Istanbul Istanbul, Fatih Turkey 34098

    Sponsors and Collaborators

    • Istanbul University - Cerrahpasa (IUC)

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    tugba yesilyurt dogu, medical doctor, Istanbul University - Cerrahpasa (IUC)
    ClinicalTrials.gov Identifier:
    NCT05852899
    Other Study ID Numbers:
    • 144674
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 12, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by tugba yesilyurt dogu, medical doctor, Istanbul University - Cerrahpasa (IUC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2023