UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014564 |
|---|---|
| Receipt number | R000016942 |
| Scientific Title | Influences of general anesthesia on respiratory resistance |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2017/05/08 12:57:39 |
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Basic information
Public title
Influences of general anesthesia on respiratory resistance
Acronym
Influences of general anesthesia on respiratory resistance
Scientific Title
Influences of general anesthesia on respiratory resistance
Scientific Title:Acronym
Influences of general anesthesia on respiratory resistance
Region
| Japan |
Condition
Condition
Patients who take general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in respiratory resistance and reactance using respiratory suction or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in respiratory resistance and reactance
Key secondary outcomes
patients have airway stimulation when big changes in respiratory resistance and reactance are detected
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Tracheal suction before extubation
Interventions/Control_2
No tracheal suction before extubation
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
Patients who take general anesthesia
Key exclusion criteria
Patients who take an airway operation
Patients with a lot of sputum
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
ane052@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
ane052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
KAKENHI (Grants-in-Aid for Scientific Research) from Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00184
Org. issuing International ID_1
JMACCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016942
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
