UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042460 |
|---|---|
| Receipt number | R000048470 |
| Scientific Title | Effect of pressure sensor on tracheal intubation education |
| Date of disclosure of the study information | 2020/11/23 |
| Last modified on | 2024/11/21 09:03:09 |
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Basic information
Public title
Effect of pressure sensor on tracheal intubation education
Acronym
Effect of pressure sensor on tracheal intubation education
Scientific Title
Effect of pressure sensor on tracheal intubation education
Scientific Title:Acronym
Effect of pressure sensor on tracheal intubation education
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the usefulness of pressure sensor in tracheal intubation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The pressure on the teeth during tracheal intubation is reduced by using the sensor.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Use of sensor
Interventions/Control_2
unused sensor
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
| 23 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Initial residents
Key exclusion criteria
none
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Yamasaki |
Organization
Matsue city hospital
Division name
Anesthesiolosy
Zip code
6908509
Address
32-1 Noshira-cho, Matsue City, Shimane Prefecture
TEL
0852-60-8000
yahho700@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Yamasaki |
Organization
Matsue city hospital
Division name
Anesthesiolosy
Zip code
6908509
Address
32-1 Noshira-cho, Matsue City, Shimane Prefecture
TEL
0852-60-8000
Homepage URL
yahho700@yahoo.co.jp
Sponsor or person
Institute
Matsue city hospital
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
other
Name of secondary funder(s)
other
IRB Contact (For public release)
Organization
Matsue city hospital
Address
32-1 Noshira-cho, Matsue City, Shimane Prefecture
Tel
0852-60-8000
yahho700@yahoo.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
| 2020 | Year | 11 | Month | 23 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048470
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048470
Number of participants that the trial has enrolled
16
Results
The force on the teeth was 8.44(5.27-11.61) in the C group and 4.60(3.78-5.42) in the S group.
The force applied to the teeth was significantly lower in the group (p<0.05)
Results date posted
| 2023 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
16 Residents were assigned
Participant flow
16 Residents were randomly divided into two groups: group S(with sensor) and group C (without sensor).
Adverse events
none
Outcome measures
The force on the teeth was 8.44(5.27-11.61) in the C group and 4.60(3.78-5.42) in the S group.
The force applied to the teeth was significantly lower in the group (p<0.05)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048470
