UMIN-ICDS Clinical Trial

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

near-hanging

Classification by specialty

Orthopedics	Emergency medicine	Intensive care medicine
Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

215-rinri@mail.hosp.go.jp

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

Email

215-rinri@mail.hosp.go.jp

Institute

NHO Tokyo Medical Center

Institute

Department

Personal name

Organization

None.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of NHO Tokyo Medical Center

Address

2-5-1, Higashigaoka, Meguro, Tokyo

Tel

+81334110111

Email

215-rinri@mail.hosp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

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 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.

Registered date

2023

Year

10

Month

14

Day

Last modified on

2023

Year

10

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059693