Supracondylar FractureNCT04694469
Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures
An observational study of Supracondylar Fracture and Morbidity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Supracondylar Fracture, Morbidity
- What is being tested?
- Closed reduction and percutaneous pinning (CRPP)
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2019to 21 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: paediatric population with supracondylar humeral fractures
Who may be able to join
- aged 5 to 12 years
- had supracondylar humeral fractures,
- underwent CRPP
- under general anaesthesia
- American Society of Anesthesiologists (ASA) physical status I to III
Who cannot join
- Surgical procedures outside the operating room
- parental refusing the study protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Supracondylar Fracture, Morbidity
- Being tested
- Closed reduction and percutaneous pinning (CRPP)
- Keywords
- supracondyler humerus fracture, night time operation, sleep deprivation, closed reduction and percutaneous pinning, CRPP
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed reduction and percutaneous pinning (CRPP)Procedure or surgery
Operated for supracondylar humeral fractures
| Study group | Role | What they receive |
|---|---|---|
| Group Day | operated at 07:30 AM - 06:30 PM Receives: Procedure: Closed reduction and percutaneous pinning (CRPP) | |
| Group Night | operated at 06:30 PM - 07:30 AM Receives: Procedure: Closed reduction and percutaneous pinning (CRPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
30 days morbidity
Measured: one month
Operation duration
time between anesthesia induction and anesthesia emergence
Measured: intraoperative
Secondary outcomes (1)
Mortality
30 days mortality
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start26 Jun 2019
- Primary completion16 Nov 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supracondylar FractureStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Mehmet I. Buget, Assoc. Prof, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyNur Canbolat, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, AnesthesiologyChasan Memet Chousein, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and TraumatologyAli Ersen, Assoc. Prof, Study chair, Istanbul Unıversit Istanbul Faculty of Medicine, Orthopedics and TraumatologyKemalettin Koltka, Assoc. Prof, Study director, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694469
- Sponsor's protocol ID
- 2019/266
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30151989Chacko 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.
PubMed 21825947
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy
- ClinicalTrials.gov ID
- NCT04694469
- Acronym / sponsor ID
- 2019/266
- Conditions
- Supracondylar Fracture, Morbidity
- Keywords
- supracondyler humerus fracture, night time operation, sleep deprivation, closed reduction and percutaneous pinning, CRPP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Day | – | Procedure: Closed reduction and percutaneous pinning (CRPP)operated at 07:30 AM - 06:30 PM |
| Group Night | – | Procedure: Closed reduction and percutaneous pinning (CRPP)operated at 06:30 PM - 07:30 AM |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- paediatric population with supracondylar humeral fractures
Key inclusion criteria (5 listed)
- aged 5 to 12 years
- had supracondylar humeral fractures,
- underwent CRPP
- under general anaesthesia
- American Society of Anesthesiologists (ASA) physical status I to III
Key exclusion criteria (2 listed)
- Surgical procedures outside the operating room
- parental refusing the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed reduction and percutaneous pinning (CRPP)Operated for supracondylar humeral fractures | Procedure or surgery | Group Day, Group Night |
Primary outcome
Morbidity
Time frame: one month
30 days morbidity
Operation duration
Time frame: intraoperative
time between anesthesia induction and anesthesia emergence
1 secondary outcome
Mortality
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 30151989Tessler 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.
- Background: PubMed 21825947Chacko 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet I. Buget, Assoc. Prof principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Nur Canbolat, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Chasan Memet Chousein, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Fracture and Morbidity, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.