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
Not Applicable
- Conditions
- Patients undergoing spinal surgery under the Transcranial muscle evoked potential monitoring
- Registration Number
- JPRN-UMIN000007977
- Lead Sponsor
- Hiroshima University Hospital,Department of Central Operation Theater
- Brief Summary
o 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who refused installation of tooth protector
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of the transformation of tracheal tube
- Secondary Outcome Measures
Name Time Method The incidence of adverse events (injury of tongue, lip, oral mucosa, teeth , maxilla and mandible)