UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060795 |
|---|---|
| Receipt number | R000069015 |
| Scientific Title | Comparison between peripheral perfusion index and nailfold microcirculation: a single-center prospective observational study |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/02 11:13:51 |
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Basic information
Public title
Comparison between peripheral perfusion index and nailfold microcirculation: a single-center prospective observational study
Acronym
Comparison between peripheral perfusion index and nailfold microcirculation: a single-center prospective observational study
Scientific Title
Comparison between peripheral perfusion index and nailfold microcirculation: a single-center prospective observational study
Scientific Title:Acronym
Comparison between peripheral perfusion index and nailfold microcirculation: a single-center prospective observational study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Anesthesiology | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Peripheral Perfusion Index (PPI) derived from pulse oximetry quantifies peripheral circulation noninvasively and conveniently based on the pulse waveform amplitude and has been increasingly used in clinical research. Microcirculation is an important factor related to prognosis, but continuous assessment in routine practice is difficult because dedicated devices are required. Nailfold Video Capillaroscopy (NVC) can quantify nailfold microcirculation, yet it is not widely used in general clinical practice. If PPI correlates with NVC metrics, PPI may serve not only as a peripheral perfusion indicator but also as a surrogate marker of microcirculation. Primary objective is to evaluate the association between pulse oximetry-derived PPI (PAI and PI) and nailfold microcirculation metrics assessed by NVC (capillary blood flow velocity and capillary diameter).
Basic objectives2
Others
Basic objectives -Others
PPI values differ by manufacturer (e.g., pulse-amplitude index [PAI] and perfusion index [PI]), and clarifying the relationship between PAI and PI is important for cross-device comparison and consistent evaluation. Secondary objective is to clarify the relationship between PAI and PI and to develop conversion equations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation (Pearson r with 95% CI) between PAI/PI and simultaneously measured nailfold capillary blood flow velocity and capillary diameter under each temperature condition (16 C, 22 C, 28 C).
Key secondary outcomes
Regression-based conversion equations between PAI and PI
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults (staff of Department of Anesthesiology, operating room nurses, and clinical engineers at Nagasaki University Hospital).
2. Able to provide written informed consent.
Key exclusion criteria
1. Nail polish or other decorations on fingers.
2. Current smoker.
3. Underlying disease under active treatment.
4. People without cuticles
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | MORIMOTO |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
tmorimoto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | MORIMOTO |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
Homepage URL
tmorimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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 for Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4 Sakamoto, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 10 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study.
Measurements are performed under three ambient temperature conditions (16 C, 22 C, and 28 C). At each condition, data are collected 5 minutes after entering the room. PAI and PI are measured simultaneously using pulse oximeter probes attached to the dominant index and ring fingers. Nailfold microcirculation is assessed on the dominant middle finger using nailfold video capillaroscopy (NVC), and capillary blood flow velocity and capillary diameter (and related metrics) are evaluated. SpO2, noninvasive blood pressure, heart rate, body temperature, and a 10-point comfort VAS are recorded simultaneously. The order of temperature conditions is not fixed. All procedures are noninvasive and do not involve therapeutic intervention.
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069015
