UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013643 |
|---|---|
| Receipt number | R000015924 |
| Scientific Title | Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind. |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2014/04/04 21:15:52 |
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Basic information
Public title
Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Acronym
Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Scientific Title
Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Scientific Title:Acronym
Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Region
| Japan |
Condition
Condition
Surgical case under temporary stomach tube insertion
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The success rate of gastric tube insertion.
2.Time required for gastric tube insertion.
Key secondary outcomes
1.The incidence of intratracheal aberration.
2.The incidence of oral hemorrhage.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The group of gastric tube transorally insertion under visual control with the use of video laryngoscope King Vision.
Interventions/Control_2
The group of gastric tube transorally insertion under blind.
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
Patients undergoing surgery under temporary stomach tube insertion.
Key exclusion criteria
1.Patients who have severe disorder of blood coagulaton.
2.Patients with esophagus varix.
3.Patients who have loose tooth.
4.Patients with trismus.
5.Patients with esophagus hiatus hernia.
6.Patients with basilar fracture.
7.Patients who are ineligible in the opinion of the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
Address
20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL
029-354-5111
t-okabe@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
Address
20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL
029-354-5111
Homepage URL
t-okabe@nms.ac.jp
Sponsor or person
Institute
Hitachi, Ltd. Hitachinaka General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is separate from "Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind:UMIN000011014".There is no overlap data.
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2014 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015924
