UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049484 |
|---|---|
| Receipt number | R000056350 |
| Scientific Title | A Prospective study of Appropriate DLT Diameter in Japanese Women Based on Ultrasound Measurement of Circumscribed Cartilage Diameter |
| Date of disclosure of the study information | 2022/11/12 |
| Last modified on | 2024/08/18 11:12:25 |
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Basic information
Public title
A Prospective study of Appropriate DLT Diameter in Japanese Women Based on Ultrasound Measurement of Circumscribed Cartilage Diameter
Acronym
A Prospective study of Appropriate DLT Diameter in Japanese Women Based on Ultrasound Measurement of Circumscribed Cartilage Diameter
Scientific Title
A Prospective study of Appropriate DLT Diameter in Japanese Women Based on Ultrasound Measurement of Circumscribed Cartilage Diameter
Scientific Title:Acronym
A Prospective study of Appropriate DLT Diameter in Japanese Women Based on Ultrasound Measurement of Circumscribed Cartilage Diameter
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery / Patients undergoing thoracic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure cricoid ring size by ultrasound testing in small Japanese women. Appropriate double lumen tube (DLT) size is predicted with measured cricoid ring size. We analysis an association of predicted DLT size and patient information (height, weight, body mass index, age). We want to know cut-off point with 32Fr and 35Fr DLT.
Patients undergoing thoracic surgery is used DLT predicted by cricoid ring size.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Appropriate double rumen tube size
Key secondary outcomes
sex(male/female), age, height, weight, body mass index, tracheal tube size(Internal diameter / outer diameter), tracheal tube type, tracheal tube exchange after tracheal intubation, there throat, hoarseness
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients with height less than 160 cm
2.ASA-PS 1-3/elective surgery
3.Patients with written informed consent
Key exclusion criteria
1.emergency surgery
2.Inability to measure cricoid cartilage diameter with ultrasound equipment (neck surgery, neck trauma, Intubated at the time consent is obtained)
3.Patient with airway narrowing (tumor, radiation, tracheostomy)
4.Airway edema(severe hypothyroid)
5.Malformation of airway or larynx
6.Patient with hoarseness or sore throat
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kusaba |
Organization
Saga-ken medical centre Koseikan
Division name
Department of anesthesia
Zip code
8408571
Address
400, Kase-machi, Saga-shi, Saga, Japan
TEL
0952242171
knsha612@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kusaba |
Organization
Saga-ken medical centre Koseikan
Division name
Department of anesthesia
Zip code
8408571
Address
400, Kase-machi, Saga-shi, Saga, Japan
TEL
0952242171
Homepage URL
rinsho@koseikan.jp
Sponsor or person
Institute
Comprehensive Clinical Research Institute, Saga-ken medical center Koseikan
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koseikan Sogo Rinsho Kenkyujyo
Address
400, Kase-machi, Saga-shi, Saga, Japan
Tel
0952242171
rinsho@koseikan.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
| 2022 | Year | 11 | Month | 12 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 20 | Day |
Other
Other related information
The tracheal diameter was measured and recorded using an ultrasound device. The appropriate DLT diameter for the patients in question was estimated and recorded using criteria presented in previous studies. For patients undergoing respiratory surgery, the estimated DLT diameter was used to determine the DLT size for the patient.
Management information
Registered date
| 2022 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056350
