UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019804 |
|---|---|
| Receipt number | R000022881 |
| Scientific Title | Comparison of pressure magnitude and pressure distribution on the blade during laryngoscopy with cervical spine fixation cases |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2021/05/21 15:34:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of pressure magnitude and pressure distribution on the blade during laryngoscopy with cervical spine fixation cases
Acronym
Comparison of pressure magnitude and pressure distribution on the blade during laryngoscopy
Scientific Title
Comparison of pressure magnitude and pressure distribution on the blade during laryngoscopy with cervical spine fixation cases
Scientific Title:Acronym
Comparison of pressure magnitude and pressure distribution on the blade during laryngoscopy
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia for more than 18 years of age
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the cervical spine fixed cases, it compares the pressure magnitude and the pressure distribution in accordance with the blade of the video laryngoscope, to examine its safety and usefulness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pressure magnitude and pressure distribution in accordance with the blade of the video laryngoscope
Key secondary outcomes
Comparison of different video laryngoscopes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Tracheal intubation using the McGRATH MAC blade
Interventions/Control_2
Tracheal intubation using the McGRATH X blade
Interventions/Control_3
Tracheal intubation using the King Vision
Interventions/Control_4
The cervical spine fixed with a neck collar
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of the enforcement plan to general anesthesia
Key exclusion criteria
Patients tracheal intubation impossible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Shoda |
Organization
Toyooka public hospitals' association
Division name
Department of Anesthesiology
Zip code
668-8501
Address
1094 Tobera,Toyooka City,Hyogo
TEL
0796-22-6111
tatsuo-magaribuchi@toyookahp-kumiai.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kono |
Organization
Toyooka public hospitals' association
Division name
Department of Anesthesiology
Zip code
668-8501
Address
1094 Tobera,Toyooka City,Hyogo
TEL
0796-22-6111
Homepage URL
konotori-konotori@gaia.eonet.ne.jp
Sponsor or person
Institute
Department of Anesthesiology,Toyooka public hospitals' association
Institute
Department
Personal name
Funding Source
Organization
Toyooka public hospitals' association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Ethics Committee,Toyooka public hospitals' association
Address
1094 Tobera,Toyooka City,Hyogo
Tel
0796-22-6111
kanri.toyooka@toyookahp-kumiai.or.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
公立豊岡病院組合立豊岡病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2021 | 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=R000022881
