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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033361
Receipt No. R000038034
Official scientific title of the study 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 2018/07/11

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Basic information
Official scientific title of the study Dynamic preload indices during recruitment maneuver as a predictor of fluid responsiveness in patients undergoing one-lung ventilation
Title of the study (Brief title) 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 Koichi Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Email suehirokoichi@yahoo.co.jp

Public contact
Name of contact person Koichi Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Homepage URL
Email suehirokoichi@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038034

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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