Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures

Completed

• Conditions: Morbidity; Supracondylar Fracture
• Interventions: Procedure: Closed reduction and percutaneous pinning (CRPP)

• Registration Number: NCT04694469
• Lead Sponsor: Istanbul University

Brief Summary

This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

Detailed Description

Supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (CRPP). The presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. For this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. Sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance.

Study Timeline

• Study Start: 2019-06-26
• Primary Completion: 2019-11-16
• Study Completion: 2020-01-21
• Study First Submitted: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• aged 5 to 12 years
• had supracondylar humeral fractures,
• underwent CRPP
• under general anaesthesia
• American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria

• Surgical procedures outside the operating room
• parental refusing the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Day	Closed reduction and percutaneous pinning (CRPP)	operated at 07:30 AM - 06:30 PM
Group Night	Closed reduction and percutaneous pinning (CRPP)	operated at 06:30 PM - 07:30 AM

Primary Outcome Measures

Name	Time	Method
Morbidity	one month	30 days morbidity
Operation duration	intraoperative	time between anesthesia induction and anesthesia emergence

Secondary Outcome Measures

Name	Time	Method
Mortality	one month	30 days mortality

Trial Locations

Locations (1)

Istanbul University, Faculty of Medicine; 🇹🇷 Istanbul, Fatih, Turkey