UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036548 |
|---|---|
| Receipt number | 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 | 2021/10/20 12:20:39 |
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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
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
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
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
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
https://link.springer.com/article/10.1007%2Fs10877-021-00736-7
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10877-021-00736-7
Number of participants that the trial has enrolled
30
Results
Twenty patients (67%) were fluid responders. All Doppler images for carotid flow time were obtained within 30s. Changes in the corrected flow time accurately predicted fluid responsiveness (area under the curve: 0.82, 95% CI 0.64-0.94, p=0.002). The optimal threshold for changes in the corrected flow time was -11.7% with a sensitivity of 95.0% (95% CI 75.1-99.9%) and a specificity of 80.0% (95% CI 44.4-97.5%).
Results date posted
| 2021 | Year | 10 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty patients undergoing general anesthesia in the supine position were prospectively enrolled.
Participant flow
Flow time was measured on Doppler images of the common carotid artery. Carotid flow time, heart rate, stroke volume, stroke volume variation, and pulse pressure variation were recorded before and after a recruitment maneuver at a continuous airway pressure of 30 cmH2O for 30 s, and before and after volume expansion with 250 mL for 10 min.
Adverse events
None
Outcome measures
Patients were defined as fluid responders if the increase in stroke volume was>10% after volume expansion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041643
