UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048470 |
|---|---|
| Receipt number | R000055241 |
| Scientific Title | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/12/02 08:12:52 |
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Basic information
Public title
Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Acronym
Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Scientific Title
Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Scientific Title:Acronym
Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Region
| Japan |
Condition
Condition
Tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate that using the stylet with the proximal bended 45 degrees forward facilitates intubation compared to using the stylet with the proximal bended 45 degrees to the right under using a McGRATH videolaryngoscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Time for endotracheal tube induction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees forward.
Interventions/Control_2
Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees to the right.
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
Ptients with anticipated ventilator or intubation difficulties
Patients with serious cerebrovascular disease, ischemic heart disease, or respiratory failure
Isolated pulmonary ventilation case
Awake intubation by bronchoscope
Naso-tracheal intubation
Tracheostomy patient
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ringa |
| Middle name | |
| Last name | You |
Organization
JCHO Chukyo Hospital
Division name
Department of Anesthesiology
Zip code
457-8510
Address
1-1-10, Sanjou, Minami, Nagoya, Aichi
TEL
052-691-7151
tai_1_lan@icloud.com
Public contact
Name of contact person
| 1st name | Ringa |
| Middle name | |
| Last name | You |
Organization
JCHO Chukyo Hospital
Division name
Department of Anesthesiology
Zip code
457-8510
Address
1-1-10, Sanjou, Minami, Nagoya, Aichi
TEL
052-691-7151
Homepage URL
tai_1_lan@icloud.com
Sponsor or person
Institute
JCHO Chukyo Hospital
Department of Anesthesiology
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of JCHO Chukyo hospital
Address
1-1-10, Sanjou, Minami, Nagoya, Aichi
Tel
052-691-7151
tai_1_lan@icloud.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
JCHO中京病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
90
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 02 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055241
