UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054483 |
|---|---|
| Receipt number | R000062230 |
| Scientific Title | Frequency and characteristics of emergency calls for suspected acute carbon monoxide poisoning related to water pipe (shisha) smoking |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2025/01/15 20:48:50 |
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Basic information
Public title
Emergency calls for suspected carbon monoxide poisoning related to water pipe smoking
Acronym
Emergency calls related to water pipe smoking
Scientific Title
Frequency and characteristics of emergency calls for suspected acute carbon monoxide poisoning related to water pipe (shisha) smoking
Scientific Title:Acronym
Emergency calls for suspected acute carbon monoxide poisoning related to water pipe smoking
Region
| Japan |
Condition
Condition
Acute carbon monoxide poisoning related to water pipe (shisha) smoking
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the epidemiology of emergency cases of suspected acute carbon monoxide poisoning related to water pipe (shisha) smoking responded to by emergency medical services (EMS).
Basic objectives2
Others
Basic objectives -Others
Number of emergency cases of suspected acute carbon monoxide poisoning related to water pipe (shisha) smoking responded to by EMS.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of emergency cases of suspected acute carbon monoxide poisoning related to water pipe (shisha) smoking responded to by EMS.
Key secondary outcomes
Call time of the incident; place of smoking; patient characteristics including employment situation, sex, age, symptoms, estimated smoking time, and alcohol use; transportation; administration of oxygen; type of medical institution; name of the injury or illness at the initial visit, severity of injury or illness at the initial visit; COHb levels of patients treated at a tertiary emergency medical facility.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Emergency calls for patients who smoked a water pipe or were working in water pipe cafes between January 2018 and June 2023 in the southwestern area of Tokyo.
Key exclusion criteria
not obviously related to water pipe
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | SHIMIZU |
Organization
Third fire district headquarter, Tokyo Fire Department
Division name
Administration Branch
Zip code
1540024
Address
33-21, Sangenjyaya 2 choume, Setagaya-ku, Tokyo
TEL
03-3418-0119
dai3honbu@tfd.metro.tokyo.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | SHIMIZU |
Organization
Third fire district headquarter, Tokyo Fire Department
Division name
Administration Branch
Zip code
1540024
Address
33-21, Sangenjyaya 2 choume, Setagaya-ku, Tokyo
TEL
03-3418-0119
Homepage URL
dai3honbu@tfd.metro.tokyo.jp
Sponsor or person
Institute
Third fire district headquarter, Tokyo Fire Department
Institute
Department
Personal name
SHIMIZU Tetsuya
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
Japanese Society for Emergency Medicine
Address
2-2-3,Nakano,Nakano-ku,Tokyo
Tel
03-3384-8177
jsem_jimu@herusu-shuppan.co.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
| 2024 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsem/27/5/27_606/_article/-char/ja
Number of participants that the trial has enrolled
64
Results
A total of 64 cases were included. Patients were mostly in their 20s with loss of consciousness or vomiting. Symptoms occasionally developed in patients who smoked for less than 30 minutes. Most patients were classified as mild cases. Two patients were classified as severe cases. The mean COHb level of the three patients treated at a tertiary emergency medical facility was 18.5%.
Results date posted
| 2025 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included emergency calls for patients who smoked a water pipe or were working in water pipe cafes between January 2018 and June 2023 in the southwestern area of Tokyo.
Participant flow
Adverse events
Outcome measures
Case characteristics, including carboxyhemoglobin (COHb) levels, of patients treated at a tertiary emergency medical facility were obtained from EMS and hospital records.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a descriptive study. This study includes emergency calls for patients who smoked a water pipe or were working in water pipe cafes between January 2018 and June 2023 in the southwestern area of Tokyo. Case characteristics, including COHb levels, of patients treated at a tertiary emergency medical facility are obtained from EMS and hospital records.
Management information
Registered date
| 2024 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062230
