UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033653 |
|---|---|
| Receipt number | 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 12:38:53 |
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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
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
chibi_hamaguri315@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesia, Omagari Kosei Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038348
