UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062071 |
|---|---|
| Receipt number | R000071024 |
| Scientific Title | Assessment of Hemodynamic Changes Before and After Lower Limb Tourniquet Release During Orthopedic Surgery Using Carotid Artery Blood Flow: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/26 16:30:36 |
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Basic information
Public title
Assessment of Hemodynamic Changes Before and After Lower Limb Tourniquet Release During Orthopedic Surgery Using Carotid Artery Blood Flow: A Prospective Observational Study
Acronym
Assessment of Hemodynamic Changes Before and After Lower Limb Tourniquet Release During Orthopedic Surgery Using Carotid Artery Blood Flow: A Prospective Observational Study
Scientific Title
Assessment of Hemodynamic Changes Before and After Lower Limb Tourniquet Release During Orthopedic Surgery Using Carotid Artery Blood Flow: A Prospective Observational Study
Scientific Title:Acronym
Assessment of Hemodynamic Changes Before and After Lower Limb Tourniquet Release During Orthopedic Surgery Using Carotid Artery Blood Flow: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Patients undergoing lower limb orthopedic surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantitatively evaluate changes in systemic hemodynamics associated with hypotension following lower limb tourniquet release.
Basic objectives2
Others
Basic objectives -Others
This exploratory study aims to investigate the respective contributions of preload (assessed by corrected carotid flow time [FTc]) and peripheral vascular resistance (assessed by pulsatility index [PI]) to hypotension following tourniquet release in patients undergoing lower limb orthopedic surgery, by evaluating the associations between the degree of blood pressure reduction and changes in these carotid pulse-wave Doppler parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of the percentage change in MEP (mean arterial pressure) between before and 1 minute after tourniquet release with the percentage changes in FTc (corrected flow time) and PI
(perfusion index)
Key secondary outcomes
Changes in Doppler-derived parameters FTc, PI, peak systolic velocity, and carotid artery blood flow before and after tourniquet release
Influence of reflected waves on carotid systolic blood flow, as evaluated by the ratio of late systolic peak velocity to early systolic peak velocity
Changes in regional cerebral oxygen saturation before and after tourniquet release
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing lower limb orthopedic surgery under general anesthesia
ASA-PS 1-3
Key exclusion criteria
Known carotid artery disease (e.g., severe carotid artery stenosis or a history of carotid artery surgery)
Severe cardiac arrhythmias (e.g., atrial fibrillation)
Severe structural heart disease (e.g., aortic stenosis or moderate-to-severe valvular regurgitation)
Patients in whom adequate carotid pulse-wave Doppler ultrasound images cannot be obtained because of anatomical limitations
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Nagahra |
Organization
JA onomichi general hospital
Division name
Anesthesiology
Zip code
722-8508
Address
1-10-23 Hirahara Onomichi Hiroshima
TEL
0848-22-8111
j036eb@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Nagahira |
Organization
JA Onomichi general hospital
Division name
Anesthesiology
Zip code
722-8508
Address
1-10-23 Hirahara Onomichi Hiroshima
TEL
0848-22-8111
Homepage URL
j036eb@yahoo.co.jp
Sponsor or person
Institute
JA Onomichi general hospital
Institute
Department
Personal name
Yoko Nagahira
Funding Source
Organization
No
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
JA Onomichi general hospital
Address
1-10-23 Hirahara Onomichi Hiroshima
Tel
0848-22-8111
j036eb@yahoo.co.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
JA尾道総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071024
