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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014564
Receipt No. 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

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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
Last 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
Email ane052@osaka-med.ac.jp

Public contact
1st 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
Email ane052@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Department of Anesthesiology
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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