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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033653
Receipt No. R000038348
Scientific Title recruitment effect of high frequency jet ventilation superimposed on volume controlled ventilation in inspiratory phase
Date of disclosure of the study information 2018/08/15
Last modified on 2019/03/27

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Basic information
Public title recruitment effect of high frequency jet ventilation superimposed on volume controlled ventilation in inspiratory phase
Acronym recruitment effect of high frequency jet ventilation
Scientific Title recruitment effect of high frequency jet ventilation superimposed on volume controlled ventilation in inspiratory phase
Scientific Title:Acronym recruitment effect of high frequency jet ventilation
Region
Japan

Condition
Condition Open abdominal surgery
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the lung recruitment effect of high frequency jet ventilation superimposed on volume controlled ventilation in inspiratory phase
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ABG(PaO2, PaCO2), dynamic compliance and P/F ratio
Key secondary outcomes Blood pressure, hate rate and cardiac index

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Recruitment maneuver using conventional mechanical ventilation
Interventions/Control_2 Recruitment maneuver using high frequency jet ventilation superimposed on volume controlled ventilation in inspiratory phase
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Adult patient who undergoing open abdominal surgery
2. Patient signed the imformed consent to
participate in the study
Key exclusion criteria obesity(BMI>30kg/m2), obstructive pulmonary disease, restrictive pulmonary disease, arrhythmia, cardiac hypofunction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chika Ikarashi
Organization Omagari Kosei Medical Center
Division name Department of anesthesia
Zip code
Address 8-65Torimachi, Daisen, Akita, Japan
TEL +81-187-63-2111
Email chibi_hamaguri315@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chika Ikarashi
Organization Omagari Kosei Medical Center
Division name Department of Anesthesia
Zip code
Address 8-65Torimachi, Daisen, Akita, Japan
TEL +81-187-63-2111
Homepage URL
Email chibi_hamaguri315@yahoo.co.jp

Sponsor
Institute Department of Anesthesia, Omagari Kosei Medical Center
Institute
Department

Funding Source
Organization Omagari Kosei Medical Center
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
Email

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 大曲厚生医療センター(秋田県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 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
2018 Year 07 Month 09 Day
Date of IRB
2018 Year 07 Month 31 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038348

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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