UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012970 |
|---|---|
| Receipt number | R000015150 |
| Scientific Title | McGRATH MAC video-laryngoscope for insertion of a transesophageal echocardiography probe. |
| Date of disclosure of the study information | 2014/01/27 |
| Last modified on | 2015/04/29 12:03:53 |
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Basic information
Public title
McGRATH MAC video-laryngoscope for insertion of a transesophageal echocardiography probe.
Acronym
McGRATH MAC video-laryngoscope for insertion of a transesophageal echocardiography probe.
Scientific Title
McGRATH MAC video-laryngoscope for insertion of a transesophageal echocardiography probe.
Scientific Title:Acronym
McGRATH MAC video-laryngoscope for insertion of a transesophageal echocardiography probe.
Region
| Japan |
Condition
Condition
Patients, who are scheduled for elective surgery under general anesthesia and required intraoperative monitoring of TEE
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of McGRATH as an aid to TEE probe placement and compare it with that of the Macintosh laryngoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcomes observed are 1) duration of TEE probe insertion, 2) number of attempts, 3) visibility of the esophageal inlet, and 4) presence of an oropharyngeal injury.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The Macintosh laryngoscope is used to visualize passage of the TEE probe.
Interventions/Control_2
McGRATH is used to visualize passage of the TEE probe.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients, who are scheduled for elective surgery under general anesthesia and required intraoperative monitoring of TEE, are included in this study.
Key exclusion criteria
Patients with sore throat, oropharyngeal infection, or neck pain are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishida |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0236-37-2670
tisd@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ishida |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0236-37-2670
Homepage URL
tisd@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
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
| 2014 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015150
| 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 |
