UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039907 |
|---|---|
| Receipt number | R000045515 |
| Scientific Title | Multi-center Observational Choking Investigation (MOCHI) |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2024/03/26 15:44:05 |
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Basic information
Public title
Multi-center Observational Choking Investigation (MOCHI)
Acronym
MOCHI
Scientific Title
Multi-center Observational Choking Investigation (MOCHI)
Scientific Title:Acronym
MOCHI
Region
| Japan |
Condition
Condition
foreign body airway obstruction
Classification by specialty
| Pneumology | Pediatrics | Oto-rhino-laryngology |
| Emergency medicine | Intensive care medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to determine the impact of bystander foreign body (FB) removal maneuvers on survival and favorable neurological outcomes among patients with foreign body airway obstruction (FBAO).
Basic objectives2
Others
Basic objectives -Others
Our secondary objectives include:
(1) evaluating the efficacy of a variety of FB removal maneuvers, (2) identifying risk factors for unsuccessful removal and (3) evaluating the impact of time intervals from incidents of FBAO to FB removal on survival and favorable neurological outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Our primary outcome is 1-month rate of survival with minimal neurologic impairment defined as CPC 1 (good recovery) or 2 (moderate disability).
Key secondary outcomes
Our secondary outcomes include success of FB removal maneuvers and complications from the maneuvers.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All (adult and pediatric) patients who present to the emergency department with FBAO, which is defined as life-threatening mechanical airway obstruction caused by foreign body in the airway.
Key exclusion criteria
Patients who present with aspiration of sputum or gastric contents, choking with gas, drowning, unwitnessed cardiac arrest, loss of consciousness before FBAO, or a neck tumor that caused suffocation.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Norii |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-5111
saga2001072@gmail.com
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Igarashi |
Organization
Nippon Medical School Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
igarashiy@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
03-3822-2131
igarashiy@nms.ac.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
| 2020 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/10/7/e039689
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
409
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
The MOCHI (the Multi-center Observational CHoking Investigation) registry is a prospective, nationwide, observational study.
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
