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

January 4, 2021 updated by: Nur Canbolat, Istanbul University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

paediatric population with supracondylar humeral fractures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: one month
30 days morbidity
one month
Operation duration
Time Frame: intraoperative
time between anesthesia induction and anesthesia emergence
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: one month
30 days mortality
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Nur Canbolat, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
  • Principal Investigator: Mehmet I. Buget, Assoc. Prof, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2019

Primary Completion (Actual)

November 16, 2019

Study Completion (Actual)

January 21, 2020

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/266

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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