UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013535 |
|---|---|
| Receipt number | 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 | 2022/10/04 12:41:20 |
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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 | Mikito |
| Middle name | |
| Last name | Kawamata |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
kawamata@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
Homepage URL
yoshiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
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
Institutional Ethics Committee of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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
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
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
