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NCT05852899 Clinical Trial

Evaluation of Preoperative Risk Factors in Children

Preterm Birth Clinical Trial

Official title:
Evaluation of Preoperative Risk Factors in Prediction of ICU Admission in Children, An Observational Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05852899
Other study ID # 144674
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date January 4, 2023

Study information
Verified date May 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date January 4, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Tugba Yesilyurt Dogu Istanbul Istanbul, Fatih

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary ASA-PS The American Society of Anesthesiologists (ASA) physical status preoperative risk assesttment Preoperative visit period ( 20 minutes)
Primary Postoperative PICU admission Number of participants of Postoperative Pediatric Intensive Care Unit admission postoperative follow-up ( in 72 hours)
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