UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040159 |
|---|---|
| Receipt number | R000045787 |
| Scientific Title | End-expiratory occlusion test using non-invasive test to predict fluid responsiveness in the operating theatre |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2021/09/21 09:37:30 |
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Basic information
Public title
End-expiratory occlusion test using non-invasive test to predict fluid responsiveness in the operating theatre
Acronym
End-expiratory occlusion test using non-invasive test to predict fluid responsiveness in the operating theatre
Scientific Title
End-expiratory occlusion test using non-invasive test to predict fluid responsiveness in the operating theatre
Scientific Title:Acronym
End-expiratory occlusion test using non-invasive test to predict fluid responsiveness in the operating theatre
Region
| Japan |
Condition
Condition
elective surgical patients
Classification by specialty
| Anesthesiology | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate whether changes in carotid artery blood flow peak velocity measured ultrasound and changes in Perfusion index measured pulse oximeter(Masimo) could predict fluid responsiveness in elective surgical patients ventilated with 7ml/predicted body weight.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the ability of changes in carotid artery blood flow peak velocity measured ultrasound and changes in Perfusion index measured pulse oximeter(Masimo) to predict fluid responsiveness in elective surgical patients ventilated with 7ml/predicted body weight.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
volume expansion using 250ml ringer solution after EEO test
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
Elective surgical patients planned to use arterial pulse contour analysis (Flotrac).
Key exclusion criteria
Patients with
planned one lung ventilation,
low ejection fraction (EF<40%),
arterial fibrillation,
severe COPD,
planned to perform head and neck surgery,
intracranial hypertension,
right heart failure,
severe stenosis in carotid artery,
severe obesity,
are excluded
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
TEL
0486472111
yiizuka@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
TEL
0486472111
Homepage URL
yiizuka@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-8503, Japan
Tel
0486472111
yiizuka@jichi.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
| 2020 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34414489/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34414489/
Number of participants that the trial has enrolled
41
Results
Results
Sixteen patients were responders, and 25 were non-responders. The area under the receiver operating characteristics curves generated for deltaPI20 and deltaPI40 to predict response to a fluid challenge were 0.561 (95% CI, 0.374-0.749) and 0.688 (95% CI 0.523-0.852), respectively.
Conclusion
Changes in perfusion index during intraoperative EEOT in patients undergoing lung protective ventilation (7ml/kg) were unable to predict the response to fluid administration.
Results date posted
| 2021 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 19 | Day |
Baseline Characteristics
This single-center, prospective study was approved by the Institutional Review Board (S20-042). This study was conducted in accordance with the Declaration of Helsinki and registered in the University hospital Medical Information Network (UMIN000040159). The study was designed to investigate whether changes in PI and maximum velocity of the carotid artery can predict response to a fluid challenge in patients undergoing lung protective ventilation. Inclusion criteria were patients older than 20 years, scheduled elective surgery, who underwent radial artery catheter placement and cardiac output monitoring. Exclusion criteria included severe preoperative lung disease, left ventricular ejection fraction below than 40%, atrial fibrillation, right heart failure, intracranial hypertension, obesity (body mass index>35), laparoscopic surgery, surgery scheduled in the prone or lateral position, or surgery with a brachial plexus block.
Participant flow
This single-center, prospective study was approved by the Institutional Review Board (S20-042). This study was conducted in accordance with the Declaration of Helsinki and registered in the University hospital Medical Information Network (UMIN000040159). The study was designed to investigate whether changes in PI and maximum velocity of the carotid artery can predict response to a fluid challenge in patients undergoing lung protective ventilation. Inclusion criteria were patients older than 20 years, scheduled elective surgery, who underwent radial artery catheter placement and cardiac output monitoring. Exclusion criteria included severe preoperative lung disease, left ventricular ejection fraction below than 40%, atrial fibrillation, right heart failure, intracranial hypertension, obesity (body mass index>35), laparoscopic surgery, surgery scheduled in the prone or lateral position, or surgery with a brachial plexus block.
Adverse events
none
Outcome measures
The predictability of the response to fluid administration with deltaPI (changes in PI between baseline 1 and 20 (deltaPI20) or 40 seconds (deltaPI40) after endotracheal tube cramp
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045787
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