UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022005 |
|---|---|
| Receipt number | R000025356 |
| Scientific Title | Effects of Recruitment Maneuver and Positive end-Expiratory Pressure during laparoscopic surgery on ventilation distribution |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2018/12/21 16:52:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Recruitment Maneuver and Positive end-Expiratory Pressure during laparoscopic surgery on ventilation distribution
Acronym
EIT monitoring during laparoscopic surgery
Scientific Title
Effects of Recruitment Maneuver and Positive end-Expiratory Pressure during laparoscopic surgery on ventilation distribution
Scientific Title:Acronym
EIT monitoring during laparoscopic surgery
Region
| Japan |
Condition
Condition
Impairment of ventilation distribution during laparoscopic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effect of recruitment maneuver and ventilator settings on ventilation distribution by electrical impedance tomography during changing position and pnemoperitoneum in the patients undergoing laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase in ventilation distribution in dorsal part of the lung by recruitment maneuver and high PEEP setting during trendelenburg position and pneumoperitonium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Set the PEEP level at 15cmH2O following recruitment maneuver until the end of surgery
Interventions/Control_2
Set the PEEP level at 5cmH2O following recruitment maneuver until the end of surgery
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) Age of >20, <80
2) undergo the laparoscopic surgery for lower abdomen
3) Witten informed consent
4) Physical Status 1 or 2 classified by American Heart Association
Key exclusion criteria
1) Impaired lung function (COPD grade > 3, or FEV1s < 1000ml)
2) Chronic heart failure (Cardiac index < 1.8L/m2, NYHA > or = 3 )
3)Unstable hemodynamics needing inotropic agents
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Shono |
Organization
Shimane University
Division name
Department of Anesthesiology, Faculty of medicine
Zip code
Address
Enya 89-1, Izumo city, Shimane
TEL
0853202295
atsukos@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Shono |
Organization
Shimane University
Division name
Department of Anesthesiology, Faculty of medicine
Zip code
Address
Enya 89-1, Izumo city, Shimane
TEL
0853202295
Homepage URL
atsukos@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025356
