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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013535
Receipt No. R000015802
Scientific Title McGRATH MAC video laryngoscope facilitates nasogastric tube introduction in intubated patients.
Date of disclosure of the study information 2014/03/27
Last modified on 2016/05/16

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Basic information
Public title McGRATH MAC video laryngoscope facilitates nasogastric tube introduction in intubated patients.
Acronym McGRATH MAC facilitate nasogastric tube introduction.
Scientific Title McGRATH MAC video laryngoscope facilitates nasogastric tube introduction in intubated patients.
Scientific Title:Acronym McGRATH MAC facilitate nasogastric tube introduction.
Region
Japan

Condition
Condition Patients who were required nasogastric tube introduction under tracheal intubated.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined whether McGRATH MAC facilitates nasogastric tube introduction compared to Macintosh laryngoscope in intubated patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration required for nasogastric tube introduction and view of esophageal orifice.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Introduction of the nasogastric tube using McGRATH MAC.
Interventions/Control_2 Introduction of the nasogastric tube using Macintosh laryngoscope.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients of ASA physical status 1-2 who were scheduled for elective surgery under general anaesthesia requiring nasogastric tube introduction.
Key exclusion criteria Patients who had the criteria for difficult intubation or abnormal airway anatomy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikito Kawamata
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Email kawamata@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Yoshiyama
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Homepage URL
Email yoshiyama@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
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
2014 Year 03 Month 27 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 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
2014 Year 03 Month 27 Day
Last modified on
2016 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015802

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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