UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053976 |
|---|---|
| Receipt number | R000061613 |
| Scientific Title | Investigation of clinical availability of new simple tracheal intubation method using brochofibersope |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/03/26 20:05:32 |
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Basic information
Public title
Investigation of clinical availability of new simple tracheal intubation method using brochofibersope
Acronym
Novel tracheal intubation with bronchofiberscope
Scientific Title
Investigation of clinical availability of new simple tracheal intubation method using brochofibersope
Scientific Title:Acronym
Novel tracheal intubation with bronchofiberscope
Region
| Japan |
Condition
Condition
Patients receiving general anesthesia with tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tracheal intubation using bronchoscopy during general anesthesia is an essential technique in patients in which the conventional intubation methods is difficult such as due to mobid obesity or impaired mouth opening coupled with facial fractures. However, aid of bronchoscopy for tracheal intubation is also useful in other usual cases, such as patients with minor mouth opening problems including temporomandibular joint disorder, fragile teeth, and cervical spondylosis. Therefore, bronchoscopy-assisted intubation has a wide range of clinical indications. However, bronchoscopy-aassisted intubation is a difficult procedure for inexperienced anesthesiologists. We have developed a novel device in which a bronchoscopy and a stylet are preassembled in a tracheal tube. By using this device, even inexperienced anesthesiologists can easily perform bronchoscopy-assisted intubation. The purpose of the present study is to examine the usefulness of our novel bronchoscopy-assisted intubation method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful or unsuccessful tracheal intubation and time required for tracheal intubation.
Key secondary outcomes
Airway mucosal injury or other complications related to tracheal intubation.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
General anesthesia cases after January 2022 at Kishiwada Tokushukai Hospital.
Key exclusion criteria
Emergency surgery cases.
Highly obese cases with BMI over 30.
Cases with complete orifice dysfunction with fracture.
Cases with intraoral bleeding.
Cases with failure to fast before surgery.
Cases with significant deformity of the oral cavity and upper airway.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tsuchiya |
Organization
Kishiwada Tokushukai Hospital
Division name
Department of Anesthesia
Zip code
5968522
Address
4-27-1 Kamori-cho, Kishiwada, Osaka, Japan
TEL
+80-72-445-9915
oxymasa@ea.mbn.or.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Tsuchiya |
Organization
Kishiwada Tokushukai Hospital
Division name
Department of Anesthesia
Zip code
5968522
Address
4-27-1 Kamori-cho, Kishiwada, Osaka, Japan
TEL
+80-72-445-9915
Homepage URL
oxymasa@ea.mbn.or.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kishiwada Tokushukai 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
Kishiwada Tokushuka Hospital
Address
4-27-1 Kamori-cho, Kishiwada, Osaka, Japan
Tel
+80-72-445-9915
oxymasa@ea.mbn.or.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 | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061613
