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

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ClinicalTrials.gov Identifier: NCT04694469

Recruitment Status : Completed

First Posted : January 5, 2021

Last Update Posted : January 5, 2021

Sponsor:

Information provided by (Responsible Party):

Nur Canbolat, Istanbul University

Study Description

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.

Condition or disease	Intervention/treatment
Supracondylar Fracture Morbidity	Procedure: Closed reduction and percutaneous pinning (CRPP)

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 Design

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Study Type :	Observational
Actual Enrollment :	82 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy
Actual Study Start Date :	June 26, 2019
Actual Primary Completion Date :	November 16, 2019
Actual Study Completion Date :	January 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arm Injuries and Disorders Fractures

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Group Day operated at 07:30 AM - 06:30 PM	Procedure: Closed reduction and percutaneous pinning (CRPP) Operated for supracondylar humeral fractures
Group Night operated at 06:30 PM - 07:30 AM	Procedure: Closed reduction and percutaneous pinning (CRPP) Operated for supracondylar humeral fractures

Outcome Measures

Primary Outcome Measures :

Morbidity [ Time Frame: one month ]
30 days morbidity
Operation duration [ Time Frame: intraoperative ]
time between anesthesia induction and anesthesia emergence

Secondary Outcome Measures :

Mortality [ Time Frame: one month ]
30 days mortality

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

paediatric population with supracondylar humeral fractures

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694469

Locations

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Turkey
Istanbul University, Faculty of Medicine
Istanbul, Fatih, Turkey, 34093

Sponsors and Collaborators

Istanbul University

Investigators

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Principal Investigator:	Mehmet I. Buget, Assoc. Prof	Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Principal Investigator:	Nur Canbolat, MD	Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Principal Investigator:	Chasan Memet Chousein, MD	Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and Traumatology
Study Chair:	Ali Ersen, Assoc. Prof	Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and Traumatology
Study Director:	Kemalettin Koltka, Assoc. Prof	Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

More Information

Publications:

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.

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.

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Responsible Party:	Nur Canbolat, Principal Investigator M.D., Istanbul University
ClinicalTrials.gov Identifier:	NCT04694469
Other Study ID Numbers:	2019/266
First Posted:	January 5, 2021 Key Record Dates
Last Update Posted:	January 5, 2021
Last Verified:	January 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Nur Canbolat, Istanbul University:


supracondyler humerus fracture night time operation sleep deprivation closed reduction and percutaneous pinning CRPP

Additional relevant MeSH terms:

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Fractures, Bone Humeral Fractures Wounds and Injuries Arm Injuries

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