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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038989
Receipt No. 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 2019/12/26

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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
Email 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
Email goh@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University

School of Medicine

Mizonokuchi Hospital
Institute
Department

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
Email 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 Enrolling by invitation
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 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 25 Day
Last modified on
2019 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044457

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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