UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045336 |
|---|---|
| Receipt number | R000051772 |
| Scientific Title | Evaluation of the success rate of tracheal intubation with or without a stylet with a defined curvature |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/10/02 08:24:27 |
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Basic information
Public title
Evaluation of the success rate of tracheal intubation with or without a stylet with a defined curvature
Acronym
Clinical study of stylet curvature to improve the success rate of endotracheal intubation
Scientific Title
Evaluation of the success rate of tracheal intubation with or without a stylet with a defined curvature
Scientific Title:Acronym
Evaluation of the success rate of tracheal intubation with or without a stylet with a defined curvature
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia by endotracheal intubation
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The success rate of endotracheal intubation with or without a stylet with a defined curvature is evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
number of tracheal intubation attempts
Key secondary outcomes
patient characteristics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The larynx is developed using a laryngoscope, and tracheal intubation is performed using a stylet with a defined curvature.
Interventions/Control_2
The larynx is developed using a laryngoscope, and tracheal intubation is performed without using a stylet.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia with endotracheal intubation
ASA physical status 1-2
Patient has agreed to participate in the study and signed informed consent form
Key exclusion criteria
emergency operation
Patients with anticipated ventilatory or intubation difficulties
Patients with serious cerebrovascular disease, ischemic heart disease, or respiratory failure
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Kawakami |
Organization
Nagano municipal hospital
Division name
Division of anesthesia
Zip code
3818551
Address
1333-1 Tomitake Nagano, Nagano, Japan
TEL
0262951199
katsuhiro_kawakami@hospital.nagano.nagano.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Kawakami |
Organization
Nagano municipal hospital
Division name
Division of anesthesia
Zip code
3818551
Address
1333-1 Tomitake Nagano, Nagano, Japan
TEL
0262951199
Homepage URL
katsuhiro_kawakami@hospital.nagano.nagano.jp
Sponsor or person
Institute
Nagano municipal hospital
Division of anesthesia
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Nagano municipal hospital
Address
1333-1 Tomitake Nagano, Nagano, Japan
Tel
0262951199
privacy@hospital.nagano.nagano.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
長野市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
statistical processing of the results and during the writing of the paper
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
| 2020 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051772
