UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050396 |
|---|---|
| Receipt number | R000057385 |
| Scientific Title | Randomized comparison study of tracheal intubation using AceScope and McGrath video laryngoscopes for cervical spine surgery patients |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2023/02/21 13:55:25 |
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Basic information
Public title
Randomized comparison study of tracheal intubation using AceScope and McGrath video laryngoscopes for cervical spine surgery patients
Acronym
Randomized comparison study of tracheal intubation using AceScope and McGrath video laryngoscopes for cervical spine surgery patients
Scientific Title
Randomized comparison study of tracheal intubation using AceScope and McGrath video laryngoscopes for cervical spine surgery patients
Scientific Title:Acronym
Randomized comparison study of tracheal intubation using AceScope and McGrath video laryngoscopes for cervical spine surgery patients
Region
| Japan |
Condition
Condition
Scheduled adult surgical patients (spine surgery)
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
[Background.
Airway management can be difficult in patients undergoing cervical spine surgery, and tracheal intubation requires a high degree of skill. Video laryngoscopes have shown a high success rate in tracheal intubation, and the use of these devices may overcome the difficulties of tracheal intubation.
[Methods.
This study will be a randomized, controlled trial of two videolaryngoscopes, AceScope and McGrath, in patients scheduled to undergo cervical spine surgery. The primary outcomes are tracheal intubation success rate, tracheal intubation time, number of attempts, and failure rate.
[Anticipated outcomes.
Comparison of the AceScope and McGrath will identify the optimal videolaryngoscope for airway provision in cervical spine surgery patients. The results of this study are expected to be useful in selecting the optimal device for airway clearance.
Adults who have performed tracheal intubation on patients or mannequins
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tracheal intubation success rate, tracheal intubation time, number of attempts, failure rate
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
| Device,equipment | Maneuver |
Interventions/Control_1
The anesthesiologist in charge selects and uses McGrath for patients scheduled to undergo cervical spine surgery before performing endotracheal intubation.
Interventions/Control_2
The anesthesiologist in charge selects and uses AceScope for patients scheduled to undergo cervical spine surgery before performing endotracheal 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cervical spine surgery patient undergoing scheduled surgery
Key exclusion criteria
Patients already intubated, emergency surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
3170077
Address
Hitachi Jounanchou 2-1-1
TEL
0294231111
musasum0710@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
3170077
Address
Hitachi Jounanchou 2-1-1
TEL
0294231111
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi General 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
Hitachi general hospital
Address
Hitachi Jounanchou 2-1-1
Tel
0294231111
musasum0710@yahoo.co.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
| 2023 | Year | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057385
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| Registered date | File name |
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