UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057657 |
|---|---|
| Receipt number | R000065878 |
| Scientific Title | The ability of changes in stroke volume induced by PEEP test to predict fluid responsiveness in patients undergoing cardiovascular surgery |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2025/04/19 14:24:29 |
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Basic information
Public title
The ability of changes in stroke volume induced by PEEP test to predict fluid responsiveness in patients undergoing cardiovascular surgery
Acronym
The ability of changes in stroke volume induced by PEEP test to predict fluid responsiveness in patients undergoing cardiovascular surgery
Scientific Title
The ability of changes in stroke volume induced by PEEP test to predict fluid responsiveness in patients undergoing cardiovascular surgery
Scientific Title:Acronym
The ability of changes in stroke volume induced by PEEP test to predict fluid responsiveness in patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To invenstigate the predictability of changes in stroke volume induced by PEEP test for fluid responsiveness in patients undergoing cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluid responsiveness (changes in stroke volume induced by Trendelenburg maneuver)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing cardiovascular surgery
2) patients who can make their own decision to participate in this study
Key exclusion criteria
1) Patients with atrial fibrillation and atrial flutter
2) Patients who are deemed inappropriate to participate in this study by the anesthesiologists
3) Patients who are deemed inappropriate to participate in this study by the surgeons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
06-6645-6125
gr-a-knky-kyoiku@omu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following the induction of general anestheisa,mechanical ventilation is started. Ventilatory settings are as the followings: tidal volume 6ml/kg and PEEP 10 cmH2O. After the recording of hemodynamic variables (blood pressure, heart rate, SVV, PPV and stroke volume), PEEP test (change the PEEP pressure 10 to 0 cmH2O) is performed. Then, Trendelenburg maneuver is performed. The hemodynamic variables are recorded after the PEEP test and the Trendelenburg maneuver.
All subjects are divided into two groups according to SV increase after the Trendelenburg maneuver (fluid responsive or unresponsive). Receiver operating characteristic curve of changes in SV induced by PEEP test is constructed to investigate the predictability for fluid responsiveness.
Management information
Registered date
| 2025 | Year | 04 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065878
