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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016631
Receipt No. R000018911
Scientific Title Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)
Date of disclosure of the study information 2015/02/25
Last modified on 2015/11/23

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Basic information
Public title Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)
Acronym Efficacy of SUZY forceps for nasogastric tube insertion
Scientific Title Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)
Scientific Title:Acronym Efficacy of SUZY forceps for nasogastric tube insertion
Region
Japan

Condition
Condition diseases requiring gastrointestinal and hepato-biliary-pancreatic surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate efficacy of SUZY forceps for nasogastric tube insertion under visual control by McGRATH MAC videolaryngoscope
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time required for nasogastric tube insertion
Key secondary outcomes success rate, frequencies and degrees of pharyngo-laryngeal complications, hemodynamic changes by nasogastric tube insertion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 nasogastric tube insertion with SUZY forceps
Interventions/Control_2 nasogastric tube insertion with Magill forceps
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 gastro-intestinal, hepato-bilial-pancreatic surgery
Key exclusion criteria patient's refusal, emergency case, a patient with full stomach, tracheostomy, predictable difficult airway, risk of hypoxia due to apnea less than 1 minute, risk of worsening of cardiovascular disease by hemodynamic change induced by McGRATH MAC, risk of hemorrhage due to upper gastrointestinal tract disease, abnormal teeth, pharyngo-laryngeal lesion, coagulopathy or low platelet counts, history of allergy and a case excluded by an attending anesthesiologist
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenta Furutani
Organization Niigata University Medical and Dental Sciences
Division name Anesthesiology
Zip code
Address 1-754, Asahimachi-Dori, Chuo-ku, Niigata
TEL 025-227-2328
Email kenta-f@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Furutani
Organization Niigata University Medical and Dental Sciences
Division name Anesthesiology
Zip code
Address 1-754, Asahimachi-Dori, Chuo-ku, Niigata
TEL 025-227-2328
Homepage URL
Email kenta-f@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
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 新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 25 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
2015 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2015 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018911

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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