Clinical trial NCT04694469: Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures
Official title: Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supracondylar Fracture
Morbidity
Keywords: supracondyler humerus fracture
night time operation
sleep deprivation
closed reduction and percutaneous pinning
CRPP
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 82
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: paediatric population with supracondylar humeral fractures

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.

Eligibility 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

Primary outcomes:
measure: Morbidity
timeFrame: one month
measure: Operation duration
timeFrame: intraoperative
Secondary outcomes:
measure: Mortality
timeFrame: one month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine
state: Fatih
Study officials:
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Mehmet I. Buget, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Nur Canbolat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and Traumatology
name: Chasan Memet Chousein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and Traumatology
name: Ali Ersen, Assoc. Prof
role: STUDY_CHAIR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Kemalettin Koltka, Assoc. Prof
role: STUDY_DIRECTOR
References:
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.
citation: 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.