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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036548
Receipt No. R000041643
Scientific Title Change in carotid corrected flow time induced by recruitment maneuver as a predictor of fluid responsiveness
Date of disclosure of the study information 2019/04/20
Last modified on 2019/04/19

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Basic information
Public title Change in carotid corrected flow time induced by recruitment maneuver as a predictor of fluid responsiveness
Acronym Change in carotid corrected flow time induced by recruitment maneuver as a predictor of fluid responsiveness
Scientific Title Change in carotid corrected flow time induced by recruitment maneuver as a predictor of fluid responsiveness
Scientific Title:Acronym Change in carotid corrected flow time induced by recruitment maneuver as a predictor of fluid responsiveness
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the reliability of changes in carotid corrected flow time induced by recruitment maneuver in predicting fluid responsiveness
Basic objectives2 Others
Basic objectives -Others To assess the reliability of changes in stroke volume and arterial pressure induced by recruitment maneuver in predicting fluid responsiveness
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 Patients undergoing general anesthesia
Key exclusion criteria 1. Atrial fibrillation, atrial flutter
2. Cerebral vascular disease
3. Decreased cardiac function (NYHA classification: 3 or more than 3, valve regurgitation: moderate or severe, ejection fraction <50%)
4. Decreased renal function (eGFR < 30mL/min/1.73m2)
5. Decreased respiratory function (%FEV1.0<70% and %VC<70%)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 545-8586
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
1st name Koichi
Middle name
Last name Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 545-8586
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)

IRB Contact (For public release)
Organization Ethics Committee of Osaka City University Graduate School of Medicine
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel 81-6-6646-6125
Email ethics@med.osaka-cu.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
2019 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 26 Day
Date of IRB
2019 Year 01 Month 24 Day
Anticipated trial start date
2019 Year 04 Month 19 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All subjects will be divided into "Responder group" or "Non-responder group" according stroke volume changes after volume loading. Receiver operating characteristic curve regarding change in carotid corrected flow time induced by recruitment maneuver will be constructed to predict fluid responsiveness.

Management information
Registered date
2019 Year 04 Month 19 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041643

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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