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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001516
Receipt No. R000001826
Scientific Title Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Date of disclosure of the study information 2008/11/19
Last modified on 2019/08/17

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Basic information
Public title Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Acronym Continous effect of anesthesia and PEEP on FRC
Scientific Title Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Scientific Title:Acronym Continous effect of anesthesia and PEEP on FRC
Region
Japan

Condition
Condition general anesthetized patients
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Oto-rhino-laryngology
Orthopedics Urology Neurosurgery
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of PEEP and PEEP timing on FRC and oxygenation during peri-operation. Continuous measuring of FRC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Study of proper PEEP level by FRC during peri-operative period and effect of PEEP on prognosis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 respirator
Interventions/Control_2 level of PEEP
Interventions/Control_3 PEEP timing
Interventions/Control_4 FRC
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 not particular
Key exclusion criteria Chronic obstructive pulmonary disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Daizoh
Middle name
Last name Satoh
Organization Tohoku university postgraduate medical school
Division name department of anesthesia and perioperative medicine
Zip code 980-8574
Address 2-1 Seiryomachi, Aoba-ku, Sendai
TEL 022-717-7321
Email ds0226@fsinet.or.jp

Public contact
Name of contact person
1st name Daizoh
Middle name
Last name atoh
Organization Tohoku university postgraduate medical school
Division name department of anesthesia and perioperative medicine
Zip code 980-8574
Address 2-1 Seiryomachi, Aoba-ku, Sendai
TEL 022-717-7321
Homepage URL
Email se803714@fsinet.or.jp

Sponsor
Institute department of anesthesia and perioperative medicine
Tohoku university postgraduate medical school
Institute
Department

Funding Source
Organization department of anesthesia and perioperative medicine
Tohoku university postgraduate medical school
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NONE
Name of secondary funder(s) NONE

IRB Contact (For public release)
Organization the Ehics committee of Tohoku University Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-7319
Email ec*rinri.hosp.tohoku.ac.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
2008 Year 11 Month 19 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
2008 Year 11 Month 19 Day
Date of IRB
2008 Year 12 Month 01 Day
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 19 Day
Last modified on
2019 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001826

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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