UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035550 |
|---|---|
| Receipt number | R000040496 |
| Scientific Title | Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/11/02 18:20:28 |
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Basic information
Public title
Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist
Acronym
The effectiveness of the McGRATH MAC
Scientific Title
Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist
Scientific Title:Acronym
The effectiveness of the McGRATH MAC
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia by tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the success rate of tracheal intubation when the resident and anesthesiologist use Macintosh laryngoscope and McGRATH MAC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of tracheal intubation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia by tracheal intubation
Key exclusion criteria
Emergency operation
Open heart surgery
Isolated pulmonary ventilation case
Laryngeal mask case
Pregnant women
Awake intubation by bronchoscope
Naso-tracheal intubation
Tracheostomy patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Ito |
Organization
Okazaki city hospital
Division name
Department of Anesthesiology
Zip code
444-8553
Address
3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan
TEL
0564-21-8111
oniheizo1745@gmail.com
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Ito |
Organization
Okazaki city hospital
Division name
Department of Anesthesiology
Zip code
444-8553
Address
3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan
TEL
0564-21-8111
Homepage URL
oniheizo1745@gmail.com
Sponsor or person
Institute
Okazaki city hospital
Institute
Department
Personal name
Funding Source
Organization
Okazaki city hospital
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
Okazaki city hospital
Address
3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan
Tel
0564-21-8111
oniheizo1745@gmail.com
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
岡崎市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 31 | 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
110
Results
The success rate of tracheal intubation
Medical intern
success rate with laryngoscope 80.4%
success rate with McGrath MAC 100%
Anesthesiologist
success rate with laryngoscope 85.9%
success rate with McGrath MAC 100%
No adverse event
Results date posted
| 2019 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 10 | Day |
Other
Other related information
Preoperative predictor of difficult airway
Management information
Registered date
| 2019 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040496
| 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 |
