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

Morbidity Clinical Trial

Official title:

Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694469
• Other study ID #: 2019/266
• Status: Completed
• Start date: June 26, 2019
• Est. completion date: January 21, 2020

Study information

• Verified date: January 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 21, 2020
• Est. primary completion date: November 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Morbidity
• Supracondylar Fracture

Intervention

Procedure:
• Closed reduction and percutaneous pinning (CRPP)
Operated for supracondylar humeral fractures

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chacko AT, Ramirez MA, Ramappa AJ, Richardson LC, Appleton PT, Rodriguez EK. Does late night hip surgery affect outcome? J Trauma. 2011 Aug;71(2):447-53; discussion 453. doi: 10.1097/TA.0b013e3182231ad7. — View Citation

Tessler MJ, Charland L, Wang NN, Correa JA. The association of time of emergency surgery - day, evening or night - with postoperative 30-day hospital mortality. Anaesthesia. 2018 Nov;73(11):1368-1371. doi: 10.1111/anae.14329. Epub 2018 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	30 days morbidity	one month
Primary	Operation duration	time between anesthesia induction and anesthesia emergence	intraoperative
Secondary	Mortality	30 days mortality	one month