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Completed

NCT Number: NCT04694469

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

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

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Key information

Conditions

Supracondylar Fracture Dyssomnias Mental Disorders Morbidity Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed reduction and percutaneous pinning (CRPP)

Procedure

Operated for supracondylar humeral fractures

Primary outcomes

  1. Morbidity

    Time frame: one month

    30 days morbidity

  2. Operation duration

    Time frame: intraoperative

    time between anesthesia induction and anesthesia emergence

Secondary outcomes

  1. Mortality

    Time frame: one month

    30 days mortality

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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