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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011014
Receipt No. R000012891
Scientific Title Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Date of disclosure of the study information 2013/06/24
Last modified on 2014/10/03

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Basic information
Public title Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Acronym Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Scientific Title Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Scientific Title:Acronym Randomized Evaluation of gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind.
Region
Japan

Condition
Condition Surgical case under stomach tube insertion
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of 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

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 transnasally insertion under visual control with the use of video laryngoscope King Vision.
Interventions/Control_2 The group of gastric tube transnasally 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 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 60

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
Email 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
Email t-okabe@nms.ac.jp

Sponsor
Institute Hitachi, Ltd. Hitachinaka General Hospital
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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 Transorally groups were separated to another study "Randomized Evaluation of transorally gastric tube insertion under visual control with the use of video laryngoscope King Vision or under blind:UMIN000013643".There is no overlap data.

Management information
Registered date
2013 Year 06 Month 21 Day
Last modified on
2014 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012891

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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