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

NCT04694469 | Completed

• 1 other identifier: 2019/266
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Fracture; Morbidity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Morbidity

  30 days morbidity

  one month

• Operation duration

  time between anesthesia induction and anesthesia emergence

  intraoperative

Secondary Outcomes (1)

• Mortality

  one month

Study Arms (2)

Group Day

operated at 07:30 AM - 06:30 PM

Procedure: Closed reduction and percutaneous pinning (CRPP)

Group Night

operated at 06:30 PM - 07:30 AM

Procedure: Closed reduction and percutaneous pinning (CRPP)

Interventions

Closed reduction and percutaneous pinning (CRPP) PROCEDURE

Operated for supracondylar humeral fractures

Group Day; Group Night

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

paediatric population with supracondylar humeral fractures

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30151989 BACKGROUND

• 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.

  PMID: 21825947 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ali Ersen, Assoc. Prof

  Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and Traumatology

  STUDY CHAIR

• Kemalettin Koltka, Assoc. Prof

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator M.D.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: June 26, 2019
• Primary Completion: November 16, 2019
• Study Completion: January 21, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

TU (1)