UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033682 |
|---|---|
| Receipt number | 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 09:39:05 |
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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
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
koboze@yahoo.co.jp
Public contact
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
koboze@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesia, Omagari Kosei Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
