UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043707 |
|---|---|
| Receipt number | R000049905 |
| Scientific Title | The association between capillary refilling time and peripheral perfusion index of surgical patients in operating room. |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2023/01/09 00:56:51 |
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Basic information
Public title
The association between capillary refilling time and peripheral perfusion index of surgical patients in operating room.
Acronym
The association between capillary refilling time and peripheral perfusion index of surgical patients in operating room.
Scientific Title
The association between capillary refilling time and peripheral perfusion index of surgical patients in operating room.
Scientific Title:Acronym
The association between capillary refilling time and peripheral perfusion index of surgical patients in operating room.
Region
| Japan |
Condition
Condition
surgical patients in operating rooms
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate peripheral perfusion index as a reliable surrogate parameter of capillary refilling time of patients in operating rooms.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate peripheral perfusion index as a reliable surrogate parameter of capillary refilling time of patients in operating rooms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cut off value of perfusion index which reflects capillary refilling time > 3secs.
Key secondary outcomes
The association between perfusion index and capillary refilling time
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
surgical patients induced general anesthesia
Key exclusion criteria
Patients with peripheral necrosis.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Jichi medical university, saitama medical center
Division name
department of critical care and anesthesiology
Zip code
3308503
Address
1-847, amanuma town, Omiya Ku, Saitama Japan
TEL
0486472111
yiizuka@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Jichi medical university, saitama medical center
Division name
department of critical care and anesthesiology
Zip code
3308503
Address
1-847, amanuma town, Omiya Ku, Saitama Japan
TEL
0486472111
Homepage URL
yiizuka@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
Jichi medical university, saitama medical center
Address
1-847, amanuma town, Omiya Ku, Saitama Japan
Tel
0486472111
yiizuka@jichi.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
| 2021 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.saudija.org/temp/SaudiJAnaesh17133-5663815_154358.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.saudija.org/temp/SaudiJAnaesh17133-5663815_154358.pdf
Number of participants that the trial has enrolled
127
Results
Prolonged CRT was observed in 27 patients. The median PI values in the non-prolonged and prolonged CRT groups were 5.0 (3.3-7.9) and 1.5 (1.2-1.9), respectively. There was a strong negative correlation between the PI and CRT (r = -0.706). The area under the receiver operating characteristic curve generated for the PI was 0.989 (95% confidence interval, 0.976-1.0). The cutoff PI value for detecting a prolonged CRT was 1.8.
Results date posted
| 2023 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 02 | Day |
Baseline Characteristics
The inclusion criteria were age > 20 years, scheduled elective surgery, or urgent surgery. The exclusion criteria were necrosis of the extremities, septic shock, or surgery with a brachial plexus block.
Participant flow
Because of the noninvasive nature of the study, the requirement for written informed consent was waived by the Research Ethics Committee of Saitama medical center Jichi medical university. Between January 2021 and July 2021, we enrolled 127 patients.
Adverse events
None
Outcome measures
There was a strong negative correlation between the PI and CRT (r=-0.706). The area under the ROC curve generated for the ability of PI to detect prolonged CRT was 0.989 (95% CI, 0.976-1.0). The cutoff PI value for detecting prolonged CRT was 1.8 (sensitivity 1.0; specificity, 0.94).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049905
