UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057481 |
|---|---|
| Receipt number | R000065678 |
| Scientific Title | Investigation of optimal monitoring methods to assess lower extremity blood flow during surgery. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2026/02/11 12:26:43 |
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Basic information
Public title
Investigation of optimal monitoring methods to assess lower extremity blood flow during surgery.
Acronym
Intraoperative lower limb blood flow assessment methods
Scientific Title
Investigation of optimal monitoring methods to assess lower extremity blood flow during surgery.
Scientific Title:Acronym
Intraoperative lower limb blood flow assessment methods
Region
| Japan |
Condition
Condition
Well leg compartment syndrome
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Vascular surgery |
| Obstetrics and Gynecology | Urology | Operative medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether laser Doppler flowmetry (LDF) is more useful than near-infrared spectroscopy (NIRS) as a method of monitoring blood flow in the lower extremity when lithotomy and head-down positions are used during surgery.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood flow measured by LDF
Key secondary outcomes
Pulse width and pulse rate measured by LDF
Tissue oxygenation index, normalized tissue hemoglobin index, oxygenated hemoglobin change, deoxygenated hemoglobin change, and total hemoglobin change measured by NIRS
Blood pressure
Percutaneous arterial oxygen saturation (SpO2)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For each endpoint, measurements are made continuously over time for five minutes each in the following positions: resting horizontal, lithotomy, lithotomy with head-down in 20 degrees, lithotomy, and resting horizontal. The total measurement period is 25 minutes.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 20 and 60
Key exclusion criteria
Individuals who experience discomfort due to changes in body position during measurement, abnormal blood pressure or SpO2 values, or irregular pulsation changes in blood flow during measurement.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tenpei |
| Middle name | |
| Last name | Akita |
Organization
Hamamatsu University School of Medicine
Division name
Department of Basic Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, JAPAN
TEL
053-435-2811
tenpak@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryuki |
| Middle name | |
| Last name | Kimura |
Organization
Hamamatsu University Hospital
Division name
Medical Instruments Administrative Center
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, JAPAN
TEL
053-435-2970
Homepage URL
kim37@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Others
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, JAPAN
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学医学部付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
30
Results
Using near-infrared spectroscopy (NIRS) and laser-Doppler flowmetry (LDF) in 30 healthy adults, we demonstrated decreases in total hemoglobin concentration and the oxygenated hemoglobin ratio in the gastrocnemius muscle during stepwise postural changes from the supine position to the lithotomy position with head-down tilt. LDF showed an increase in pulsatile flow amplitude in the lithotomy position, particularly on the plantar side, along with changes in blood flow.
Results date posted
| 2026 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 30 healthy adults, aged 20 to 59 years. There were 15 males and 15 females, with an average age of 33.5years. There was no significant difference in age distribution between the male and female groups (p = 0.25, Mann-Whitney U test). However, height and weight were significantly greater in the male group (both p < 0.001, t-test). Body mass index (BMI) was also significantly higher in the male group (p = 0.016, t-test), with an average difference of approximately 1.4 kg/m2.
Participant flow
The research subjects were given a thorough explanation of the purpose and content of the study, both verbally and in writing. Written informed consent was obtained based on the subjects' free will.
Adverse events
No adverse events occurred.
Outcome measures
The primary endpoints were five tissue oxygenation indices measured by near-infrared spectroscopy (NIRS): the tissue oxygenation index (TOI), the normalized tissue hemoglobin index (nTHI), the change in oxygenated hemoglobin (O2Hb), the change in deoxygenated hemoglobin (HHb), and the change in total hemoglobin (cHb), as well as blood flow, which was measured by laser Doppler flowmetry (LDF). The secondary endpoints included LDF pulsatility amplitude and frequency, as well as non-invasive blood pressure (NIBP) and transcutaneous arterial blood oxygen saturation (SpO2) in the lower limbs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065678
