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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Anesthesia Morbidity
• Difficult or Failed Intubation
• Premature Birth
• Preterm Birth

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)