UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Noboru Saeki
Organization	Hiroshima University Hospital
Division name	Department of Central Operation Theater
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5267
Email

Public contact
Name of contact person
Organization	Hiroshima University Hospital
Division name	Department of Central Operation Theater
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs00540-016-2220-3
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.
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/icdr_e/ctr_view.cgi?recptno=R000008897