UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038989 |
|---|---|
| Receipt number | R000044457 |
| Scientific Title | Ventilation setting to minimize physiological dead space with volumetric capnography |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2021/12/27 12:59:31 |
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Basic information
Public title
Ventilation setting to minimize physiological dead space with volumetric capnography
Acronym
Ventilation setting to minimize physiological dead space with volumetric capnography
Scientific Title
Ventilation setting to minimize physiological dead space with volumetric capnography
Scientific Title:Acronym
Ventilation setting to minimize physiological dead space with volumetric capnography
Region
| Japan |
Condition
Condition
Anaesthesia undergoing robot-assisted laparoscopic radical prostatectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To minimize physiological dead space using volumetric capnography,in which shunt dead space and alveolar dead space would indicate moderate I:E ratio.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
physiological dead space during ventilation
Key secondary outcomes
Airway, Alveolar, shunt dead space, and functional residual capacity, Total PEEP, Auto PEEP during ventilation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Using respiratory ventilation (Engstrom Caredtation, GE Healthcare), interventions start after Trendelenburg position and pneumoperitoneum were established. Using PC-VG mode, the target volume is set to 6 -8 ml/kg of ideal body weight. Respiratory rate is set to 12 bpm.
Setting 1; I:Eratio of 1:2, PEEP of 5 cmH2O.
Interventions/Control_2
Setting 2; I:E ratio of 2:1, PEEP of 0 cmH2O
Interventions/Control_3
Setting 3; I:E ratio of 3:1, PEEP of 0 cmH2O
Interventions/Control_4
Setting 4; I:E ratio of 4:1, PEEP of 0 cmH2O
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
ASA PS 1 to 2 scheduled for robot-assisted laparoscopic radical prostatectomy were considered eligible.
FVC % predicted < 100%
Key exclusion criteria
The exclusion criteria were as follows; ASA physical status 3 to 5, a history of COPD, pneumothorax and previous lung surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako Takatsu-ku kKawasaki Kanagawa
TEL
044-844-3333
goh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
5-1-1 Futako Takatsu-ku kKawasaki Kanagawa
Division name
Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako Takatsu-ku kKawasaki Kanagawa
TEL
044-844-3333
Homepage URL
goh@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
School of Medicine
Mizonokuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
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
Teikyo University School of Medicine
Address
2-11-1 Kaga Itabashi Tokyo
Tel
03-3964-9358
turb-office@teikyo-u.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
帝京大学医学部附属溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
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
| 2019 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044457
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/16 | 2020年度研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/07/16 | データ仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/07/16 | 解析データ.xlsx |
