UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054689 |
|---|---|
| Receipt number | R000062158 |
| Scientific Title | Correlation between pulse-amplitude index and capillary refill index in surgical patients under general anesthesia |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 10:55:54 |
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Basic information
Public title
Correlation between pulse-amplitude index and capillary refill index in surgical patients under general anesthesia
Acronym
Correlation between pulse-amplitude index and capillary refill index in surgical patients under general anesthesia
Scientific Title
Correlation between pulse-amplitude index and capillary refill index in surgical patients under general anesthesia
Scientific Title:Acronym
Correlation between pulse-amplitude index and capillary refill index in surgical patients under general anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing surgery for upper gastrointestinal, hepatic, and pulmonary diseases
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Concurrent peripheral circulatory failure has been noted as a prognostic factor in critically ill patients. The pulse-amplitude index (PAI) calculated from pulse oximetry is used as a peripheral circulatory index, but the cutoff value is unknown. The capillary refill index (CRI) is a new index that measures capillary refill time at the fingertip using changes in transmitted light intensity of a pulse oximeter. To simultaneously measure PAI and CRI in patients undergoing surgical procedures under general anesthesia and test the correlation. The findings will be useful in the search for cutoff values of PAI that define peripheral circulatory failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of PAI and CRI measured simultaneously before induction of anesthesia, after induction of anesthesia, 15 minutes and every 2 hours after the start of surgery, at the end of surgery, and after awakening from anesthesia
Key secondary outcomes
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
Age: 18 years and older
Surgical procedures: pneumonectomy, hepatectomy, esophagectomy, gastrectomy
Diseases: upper gastrointestinal diseases, liver diseases, and lung diseases
Key exclusion criteria
Patients who have manicured or decorated fingers.
Patients with a history of hand blood flow insufficiency due to arteriosclerotic diseases or collagen diseases.
Patients with finger defects or deformities.
Patients with a negative Allen test*
*Allen's test: A test for blood flow insufficiency in the radial and ulnar arteries. Manual compression of the radial and ulnar arteries is applied, and after the palms become pale, one of them is released, and the patient is observed for rapid recovery of palm redness (blood flow). General preoperative examination before anesthesia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Shintani |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
8528117
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
r-shintani@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Shintani |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
8528117
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
Homepage URL
r-shintani@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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@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
| 2024 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was before the study began.
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062158
