UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043351
Receipt number 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 2023/06/29 10:39:49

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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 or person

Institute

Department of Emergency and Disaster Medicine, Gifu University

Institute

Department

Personal name



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

Enrolling by invitation

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

2028 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

2023 Year 06 Month 29 Day



Link to view the page

Value
https://center6.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