UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055803 |
|---|---|
| Receipt number | R000063783 |
| Scientific Title | Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/10/12 12:43:39 |
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Basic information
Public title
Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Acronym
Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Scientific Title
Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Scientific Title:Acronym
Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Region
| Japan |
Condition
Condition
Patients aged 18 years and over undergoing standby surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC video laryngoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intubation complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
McGRATH MAC Videolaryngoscopic glottis elevation with direct elevation for tracheal intubation.
Interventions/Control_2
McGRATH MAC Videolaryngoscopic glottis elevation with indirect elevation for tracheal intubation.
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 who fulfill all of the following conditions are eligible.
1. patients scheduled for general anesthesia in standby surgery
2. patients with American Society Association physical status class I to III
3. patients who are at least 18 years of age at the time consent is obtained
4. patients with sufficient judgment to understand the study and whose written consent has been obtained.
Key exclusion criteria
1. patients with a history of intubation difficulties
2. patients with cervical spondylosis
3. patients with gastro-oesophageal reflux disease
4. patients with epiglottis cysts
5. patients with a Body Mass Index (BMI) of more than 35 kg/m2
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0611
akihri@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0611
Homepage URL
akihri@wakayama-med.ac.jp
Sponsor or person
Institute
Aki Hirai, Department of Anesthesiology, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Ethics Review Committee
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
Tel
073-441-0897
wa-rinri@wakayama-med.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
| 2024 | Year | 10 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2024 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063783
