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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043351
Receipt No. R000049403
Scientific Title An observational study about the effects of acupoint stimulation on splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography
Date of disclosure of the study information 2021/02/18
Last modified on 2021/02/17

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Basic information
Public title An observational study about the effects of acupoint stimulation on the splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography
Acronym Observation of the splanchnic hemodynamics of critically ill patients following acupoint stimulation
Scientific Title An observational study about the effects of acupoint stimulation on splanchnic hemodynamics of critically ill patients in an intensive care setting using color Doppler ultrasound sonography
Scientific Title:Acronym Observation of the splanchnic hemodynamics of critically ill patients following acupoint stimulation
Region
Japan

Condition
Condition Critically ill patients in an intensive care setting
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the effects of acupuncture stimulation on hemodynamics in the superior mesenteric artery in critically ill patients in an intensive care setting
Basic objectives2 Others
Basic objectives -Others Observation of hemodynamic changes following acupuncture stimulation
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Hemodynamics of the superior mesenteric artery measured using color Doppler ultrasound sonography
(blood flow volume of SMA)
Key secondary outcomes Diameters of SMA, RI, PI, PSV, and EDV

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 1. Inpatients in an advanced critical care center and intensive care unit at the Gifu University Hospital
2. Age >= 20 years
3. Acute coronary syndrome, heart failure, acute aortic dissection, postcardiac surgery, respiratory failure, multiple injury, brain injury, burn, renal failure, and sepsis
4. Patients who receive acupuncture treatment as decided by the attending physician
5. Patients who do not have lower leg injury and can receive acupuncture on ST36
6. Patients who provided their informed consent for this research.

Key exclusion criteria 1. Difficulty in undergoing US measurement (difficulty in maintaining resting position, abdominal injury, postabdominal surgery, and excess of intestinal gas retention)
2. Unstable hemodynamics
3. Obvious stenosis of the superior mesenteric artery
4. Remarkable arrythmia, including atrial fibrillation and other such conditions
5. Unable to use acupoint ST36 due to leg injury, burns, etc.
6. Sensory disturbance of the lower leg, including ST36 location
7. Inappropriate decision by the physician
8. Patients who did not consent to this research
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hideshi
Middle name
Last name Okada
Organization Gifu University
Division name Department of Emergency and Disaster Medicine
Zip code 501-1194
Address Yanagido-1-1, Gifu, Japan
TEL 058-230-6448
Email hideshi@gifu-u.ac.jp

Public contact
Name of contact person
1st name Hideshi
Middle name
Last name Okada
Organization Gifu University
Division name Department of Emergency and Disaster Medicine
Zip code 501-1194
Address Yanagido 1-1, Gifu, Japan
TEL 058-230-6448
Homepage URL
Email hideshi@gifu-u.ac.jp

Sponsor
Institute Department of Emergency and Disaster Medicine, Gifu University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Gifu University Graduate School of Medicine
Address Yanagido 1-1, GIfu
Tel 058-230-6059
Email rinri@gifu-u.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 岐阜大学医学部附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 18 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 03 Day
Date of IRB
2021 Year 02 Month 03 Day
Anticipated trial start date
2021 Year 02 Month 18 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of hemodynamics of the superior mesenteric artery, including blood flow volume, diameters, RI, PI, PSV, and EDV, in critically ill patients immediately after acupuncture stimulation at ST36 in clinical situation

Management information
Registered date
2021 Year 02 Month 17 Day
Last modified on
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049403

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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