UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029552 |
|---|---|
| Receipt number | R000033443 |
| Scientific Title | Lung-protective properties of expiratory flow-initiated pressure-controlled inverse ratio ventilation: A randomised controlled trial |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/04/15 00:07:14 |
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Basic information
Public title
Lung-protective properties of expiratory flow-initiated pressure-controlled inverse ratio ventilation: A randomised controlled trial
Acronym
Lung-protective properties of expiratory flow-initiated pressure-controlled inverse ratio ventilation: A randomised controlled trial
Scientific Title
Lung-protective properties of expiratory flow-initiated pressure-controlled inverse ratio ventilation: A randomised controlled trial
Scientific Title:Acronym
Lung-protective properties of expiratory flow-initiated pressure-controlled inverse ratio ventilation: A randomised controlled trial
Region
| Japan |
Condition
Condition
Consecutive subjects undergoing robot-assisted laparoscopic radical prostatectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examin that expiratory flow initiated pressure control inverse ratio ventilation would reduce dead space resulted in lung protective ventilation mode undergoing robot-assisted laparoscopic radical prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
IL-6 of arterial blood sampling obtained at the start, 2 hour later and end of surgery.
Key secondary outcomes
IL-8, IL-1, TNF
physiological dead space, airway dead space, alveolar dead space, shunt dead space, respiratory-haemodynamic parameters
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
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Volume control ventilation group
Targer PaO2>100 mmHg and PaCO2<50 mmHg.
Volume control ventilation mode.
I:E ratio of 1:2.
PEEP of 5 cmH2O.
Tidal volume of 6~8 ml/kg body weight.
Airway pressure < 30 cmH2O.
Initial respiratory rate of 12 bpm up to 18 bpm.
Interventions/Control_2
Expiratory flow initiated pressure control inverse ratio ventilation group
Targer PaO2>100 mmHg and PaCO2<50 mmHg.
PCV volume guarantee mode.
PEEP off.
Tidal volume of 6~10 ml/kg body weight.
Airway pressure < 25 cmH2O.
Inverse I/E ratio was adjusted individually by observing the expiratory flow-time wave.
Initial respiratory rate of 12 bpm up to 15 bpm.
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
American Society of Anaesthesiologists (ASA)physical status I or II scheduled to undergo elective RLRP.
Key exclusion criteria
History of pneumothorax, previous lung surgery, and ASA physical status III or worse
Target sample size
30
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 Kawasaki Kanagawa
TEL
044-844-3333
flatwood@aa.cyberhome.ne.jp
Public contact
Name of contact person
| 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 Kawasaki Kanagawa
TEL
044-844-3333
Homepage URL
flatwood@aa.cyberhome.ne.jp
Sponsor or person
Institute
Mizonokuchi Hospital, Teikyo University School of Medicine
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
| 2017 | Year | 11 | Month | 01 | 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
28
Results
There were no significant differences in serum IL-6 and IL-8 levels between the groups.
The physiological dead space ratio in the EF-initiated PC-IRV group was significantly smaller than that in the VCV group.
The physiological dead space ratio was also negatively correlated with preoperative FVC (% predicted) in the VCV group, but not correlated in the EF-initiated PC-IRV group.
Two patients required permissive hypercapnia in the VCV group, but not in the EF-initiated PC-IRV group.
Results date posted
| 2020 | Year | 04 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Now on submitting.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 14 | Day |
Last modified on
| 2020 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033443
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 研究実施計画書２０１８．８．２３修正.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/14 | data 仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/14 | Data.xlsx |
