UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033361 |
|---|---|
| Receipt number | R000038034 |
| Scientific Title | Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation |
| Date of disclosure of the study information | 2018/07/12 |
| Last modified on | 2019/01/10 09:21:40 |
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Basic information
Public title
Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation
Acronym
Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation
Scientific Title
Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation
Scientific Title:Acronym
Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the reliability of dynamic preload indices during recruitment maneuver for predicting fluid responsiveness in patients undergoing one-lung ventilation
Basic objectives2
Others
Basic objectives -Others
To assess the reliability of dynamic preload indices during recruitment maneuver for predicting fluid responsiveness in patients undergoing one-lung ventilation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in stroke volume after volume expansion
Key secondary outcomes
Changes in arterial pressure after volume expansion
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
Surgical patients undergoing one-lung ventilation
Key exclusion criteria
1) Arterial fibrillation
2) Cerebral vascular disease
3) Heart failure (NYHA classification: 3 or 4)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
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 | |
| Middle name | |
| Last name | Koichi Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City University Graduate School of Medicine
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
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
| 2018 | Year | 07 | Month | 12 | 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
A decrease in stroke volume induced by recruitement maneuver can predict fluid responsiveness in patients undergoing one-lung ventilation.
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
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All subjects are divided into "Responder group" or "Non-responder group" according stroke volume index changes after volume loading. Receiver operating characteristic curves of dynamic preload indices during recruitment maneuver are constructed to predict fluid responsiveness.
Management information
Registered date
| 2018 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038034
