UMIN-CTR Clinical Trial

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
Email	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
Email	yiizuka@jichi.ac.jp

Sponsor
Institute	Jichi Medical University Saitama Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045787