UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052502 |
|---|---|
| Receipt number | R000059693 |
| Scientific Title | Investigation of the incidence of complicated cervical injuries in near-hanging patients |
| Date of disclosure of the study information | 2023/10/14 |
| Last modified on | 2024/10/18 13:55:09 |
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Basic information
Public title
Investigation of the incidence of complicated cervical injuries in near-hanging patients
Acronym
Investigation of the incidence of complicated cervical injuries in near-hanging patients
Scientific Title
Investigation of the incidence of complicated cervical injuries in near-hanging patients
Scientific Title:Acronym
Investigation of the incidence of complicated cervical injuries in near-hanging patients
Region
| Japan |
Condition
Condition
near-hanging
Classification by specialty
| Orthopedics | Emergency medicine | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of cervical injuries among hospitalised patients due to near-hanging
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence of near-hanging associated cervical injuries which include laryngeal fracture, laryngeal deviation, spinal cord injury, cervical spine fracture, and blunt cerebrovascular injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is prevalence of a hanging-related cervical injury. We define hanging-related cervical injury as laryngeal fracture; laryngeal deviation; spinal cord injury; cervical spine fracture; or blunt cerebrovascular injury.
Key secondary outcomes
The secondary outcomes are prevalence of laryngeal fracture, laryngeal deviation, spinal cord injury, spinal concussion, cervical spine fracture, blunt cerebrovascular injury, hypoxic encephalopathy, and negative-pressure pulmonary edema, respectively.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All consecutive patients aged 18 years old or older who were hospitalised to the department of Emergency Medicine of the NHO Tokyo Medical Center due to near-hanging between April 2014 and June 2023.
Key exclusion criteria
Patients who had suffered cardiac arrest due to hanging and had been never resuscitated at the emergency department are excluded. We will also exclude the patients who had fatal injuries due to suicide means other than hanging.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tokyo Medical Center
Division name
Department of Emergency Medicine
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro, Tokyo
TEL
+81334110111
215-rinri@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tokyo Medical Center
Division name
Department of Emergency Medicine
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro, Tokyo
TEL
+81334110111
Homepage URL
215-rinri@mail.hosp.go.jp
Sponsor or person
Institute
NHO Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of NHO Tokyo Medical Center
Address
2-5-1, Higashigaoka, Meguro, Tokyo
Tel
+81334110111
215-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.ajem.2024.07.047
Number of participants that the trial has enrolled
63
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 28 | Day |
Baseline Characteristics
The median age of the patients was 42 years (interquartile range (IQR) 31 to 62), 33 (52%) were women, 37 (59%) had psychiatric dis-eases, and 20 (32%) had a history of attempted suicide. Among all included patients, 14 (22%) per-formed hanging from a height above their own, 14 (22%) attempted drug overdose simultaneously, and 25 (40%) had cardiac arrest on the scene. At admission, the median GCS score was 6 (IQR 3 to 14), and 8 (13%) patients complained of neck symptoms. On examination, there was a ligature mark and neck tenderness in 46 (73%) and 2 (3%) patients, respectively.
Participant flow
During the study period, a total of 162 patients were admitted to our ED due to hanging. Of those, 99 patients were excluded for the following reasons: 97 patients for cardiac arrest that did not achieve a return of spontaneous circulation, one for an age younger than 18 years, or one for a fatal abdominal injury caused by stabbing for a suicide attempt. Thus, the remaining 63 patients were included in the final analysis.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective, single-center, observational study will be conducted to investigate the prevalence of cervical injuries among hospitalised patients due to near-hanging between April 2014 and June 2023 by using the electronic medical records. The primary outcome is prevalence of a hanging-related cervical injury, which includes laryngeal fractures, laryngeal deviations, spinal cord injuries, cervical spine fractures, and blunt cerebrovascular injuries. The primary outcome will be determined among patients with normal consciousness and no abnormal neck symptoms and signs at admission.
Management information
Registered date
| 2023 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059693
