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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007977
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima University Hospital,Department of Central Operation Theater
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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