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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033682
Receipt No. R000038401
Scientific Title Effect of high frequency jet ventilation superimposed on volume controlled ventilation in respiratory management durng laparoscopic abdominal surgery
Date of disclosure of the study information 2018/08/10
Last modified on 2019/02/07

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Basic information
Public title Effect of high frequency jet ventilation superimposed on volume controlled ventilation in respiratory management durng laparoscopic abdominal surgery
Acronym Effect of high frequency jet ventilation during laparoscopic abdominal surgery
Scientific Title Effect of high frequency jet ventilation superimposed on volume controlled ventilation in respiratory management durng laparoscopic abdominal surgery
Scientific Title:Acronym Effect of high frequency jet ventilation during laparoscopic abdominal surgery
Region
Japan

Condition
Condition laparoscopic abdominal surgery
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify effectiveness of high frequency ventilation superimposed on volume controlled ventilation to the hypercapnia during laparoscopic abdominal surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ABG(pH, PaCO2), airway pressure and tidal volume
Key secondary outcomes ABG(PaO2)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Change of conventional mechanical ventilation for volume controlled ventilation superimposed on high frequency jet ventilation during surgery
Interventions/Control_2
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. adult patient who undergoing laparoscopic abdominal surgery
2. Patient signed the informed consent to participate in the study
Key exclusion criteria Patient with obstructive pulmonary disease or past history of spontaneous pneumothorax
Target sample size 20

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

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

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

Funding Source
Organization Department of Anesthesia, 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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 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
High frequency jet ventilation superimposed on volume controlled ventilation (S-HFJV) can decrease both Paw and PaCO2 and increase both pH and PaO2 .
S-HFJV might ameliorate respiratory acidosis and hypoxia during laparoscopic abdominal surgery.

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 Completed
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 30 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038401

Research Plan
Registered date File name
2018/12/30 研究計画書.docx

Research case data specifications
Registered date File name
2018/12/30 HFJV_protocolxlsx.pdf

Research case data
Registered date File name
2018/12/30 analysed data_2018.pdf


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