UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045950 |
|---|---|
| Receipt number | R000052326 |
| Scientific Title | Study on the effect of pulse oximeter measurement site on pulse wave transit time (PWTT) |
| Date of disclosure of the study information | 2021/11/08 |
| Last modified on | 2023/11/09 16:39:16 |
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Basic information
Public title
Study on the effect of pulse oximeter measurement site on pulse wave transit time (PWTT)
Acronym
PWTT Study
Scientific Title
Study on the effect of pulse oximeter measurement site on pulse wave transit time (PWTT)
Scientific Title:Acronym
PWTT Study
Region
| Japan |
Condition
Condition
Liver tumor, Liver cyst, Liver transplant donor
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The pulse oximeter monitoring is available to estimate cardiac output from the pulse wave transit time (PWTT). As it could be difficult to measure pulse waves from fingers with lower perfusion due to bleeding during surgery, we may use earlobes. We study to verify whether PWTT measured from earlobes is as useful as that measured from fingers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of finger-PWTT and ear-PWTT
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing liver resection
Patients undergoing anesthesia with monitoring of direct arterial pressure and central venous pressure
Patients who can understand and agree the study plan for themselves.
Key exclusion criteria
Patients with arrhythmias shown as blow:
atrial fibrillation, atrial flutter
supraventricular arrhythmia such as sinus arrhythmia
bigemini, trigemini
Patients who need pacing during surgery
Patients with liver cirrhosis
Patients who the investigators consider inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Midoriko |
| Middle name | |
| Last name | Higashi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Anesthesiology and Critical Care Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5714
higashi.midoriko.976@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Midoriko |
| Middle name | |
| Last name | Higashi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Anesthesiology and Critical Care Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5714
Homepage URL
higashi.midoriko.976@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYUSHU UNIVERSITY Center for Clinical and Translational Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5774
byshinsa@jimu.kyushu-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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.tohoku-kyoritz.jp/44jsccm/program.html
Publication of results
Published
Result
URL related to results and publications
https://www.tohoku-kyoritz.jp/44jsccm/program.html
Number of participants that the trial has enrolled
52
Results
PWTT measured using ear plethysmography is available as a substitute for change of PWTT measured using finger plethysmography.
Results date posted
| 2023 | Year | 11 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty two patients undergoing elective hepatectomy from November 2021 to April 2021.
Participant flow
A total of 311 paired reading 52 patients were collected.
Adverse events
None
Outcome measures
Primary outcome was the global agreement of all PWTT measurements. Secondary outcome was trending ability during hemodynamic changes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Put the pulse oximeters on the fingers or earlobes to measure PWTT, and investigate the correlation between finger-PWTT and ear-PWTT, changes of PWTT between before and after hemodynamic changes, and respiratory variations.
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052326
