UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033393 |
|---|---|
| Receipt number | R000037448 |
| Scientific Title | Simplified configuration of the cuff pressure using syringe |
| Date of disclosure of the study information | 2018/07/15 |
| Last modified on | 2018/07/15 10:40:40 |
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Basic information
Public title
Simplified configuration of the cuff pressure using syringe
Acronym
Configuration of the cuff pressure using syringe
Scientific Title
Simplified configuration of the cuff pressure using syringe
Scientific Title:Acronym
Configuration of the cuff pressure using syringe
Region
| Japan |
Condition
Condition
diseases enough to require surgery
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Pediatrics | Orthopedics | Anesthesiology |
| Neurosurgery | Cardiovascular surgery | Plastic surgery |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the configuration of cuff pressure of tracheal tube using 10ml syringe is possible or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the cuff pressure when plunger of syringe stops after inject air into cuff
Key secondary outcomes
cuff volume when plunger of syringe stops
a incidence of hoarseness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
inject 10ml air into cuff No.1
Interventions/Control_2
inject 10ml air into cuff No.2
Interventions/Control_3
inject 10ml air into cuff No.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
ASA physical status classification (ASA-PS) 1 or 2
Key exclusion criteria
ASA-PS 3-6
emergency operation
special intubation(one lung ventilation, nasal intubation)
patients with a history of neck surgery
obese patients(BMI>30)
minor children
patients using TEE
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tennnichi |
Organization
PHARMACEUTICAL AND HEALTH SCIENCES KANAZAWA UNIVERSITY
Division name
DEPARTMENT OF ANESTHESIOLOGY FACULTY OF MEDICINE INSTITUTE OF MEDICAL
Zip code
Address
13-1, Takaramachi Kanazawa-shi, Ishikawa
TEL
0762652434
ttennichi@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tennichi |
Organization
PHARMACEUTICAL AND HEALTH SCIENCES KANAZAWA UNIVERSITY
Division name
DEPARTMENT OF ANESTHESIOLOGY FACULTY OF MEDICINE INSTITUTE OF MEDICAL
Zip code
Address
13-1, Takaramachi Kanazawa-shi, Ishikawa
TEL
+81762652434
Homepage URL
ttennichi@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 15 | 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
| 2018 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 15 | Day |
Last modified on
| 2018 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037448
