UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007977 |
|---|---|
| Receipt number | R000008897 |
| Scientific Title | Open-label study of the efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential, comparison with previously non-treated group |
| Date of disclosure of the study information | 2012/05/20 |
| Last modified on | 2017/05/21 18:58:00 |
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Basic information
Public title
Open-label study of the efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential, comparison with previously non-treated group
Acronym
The efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
Scientific Title
Open-label study of the efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential, comparison with previously non-treated group
Scientific Title:Acronym
The efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
Region
| Japan |
Condition
Condition
Patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of the tooth protector in the patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of the transformation of tracheal tube
Key secondary outcomes
The incidence of adverse events (injury of tongue, lip, oral mucosa, teeth , maxilla and mandible)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Tooth protector
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
The patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
Key exclusion criteria
Patients who refused installation of tooth protector
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Saeki |
Organization
Hiroshima University Hospital
Division name
Department of Central Operation Theater
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5267
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University Hospital
Division name
Department of Central Operation Theater
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University Hospital,Department of Central Operation Theater
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
Address
Tel
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00540-016-2220-3
Number of participants that the trial has enrolled
Results
No endotracheal tube deformation was found in 22 patients fitted with the new mouthpiece. The incidence of tube deformation (none of 22 patients, 0 %) was significantly lower than in those who had been fitted with the gauze bite block (9 of 20 patients, 45.0 %; p < 0.001). Application of the mouthpiece resulted in no tongue or tooth injuries.
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008897
