UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032439 |
|---|---|
| Receipt number | R000036993 |
| Scientific Title | Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/05/09 08:31:48 |
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Basic information
Public title
Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Acronym
Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Scientific Title
Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Scientific Title:Acronym
Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Accuracy of cardiac output measurement by continuous non invasive arterial pressure measurement (CNAP)
Basic objectives2
Others
Basic objectives -Others
Measurement accuracy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiac output measured by CNAP is equivalent to cardiac output measured by FloTrac(R)
Key secondary outcomes
Cardiac output measured by CNAP in supine and semipro position are equivalent to cardiac output measured by FloTrac(R)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous noninvasive finger arterial pressure measurement (CNAP) is worn on two adjacent fingers from the time of general anesthesia to the end of the operation.
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
Esophageal cancer (patient undergoing esophagectomy)
Key exclusion criteria
Below 20 years, weighing less than 40 kg or 180 kg or more, BMI 35 or more, neuromuscular disease, frequent arrhythmia (atrial fibrillation, overhaul contraction of more than 10% in Holter's electrocardiogram), hypothermia below 35 degrees, upper extremity Patients who have problems with the artery (shunt, past history used as graft, vascular occlusion, Raynaud's symptom, collagen disease related to limb vessel disease), past history of artificial insertion (measuring artificial femoral head, internal fixation) on the measurement side, In the case of complete lateral decubitus operation using ventilation, when the invasive arterial pressure can not be measured
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku university graduate school of medicine
Division name
Department of anesthesia and perioperative medicine
Zip code
9808572
Address
2-1, Seiryo-machi, Aoba, Sendai, Miyagi
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Kobayashi |
Organization
Tohoku university graduate school of medicine
Division name
Department of anesthesia and perioperative medicine
Zip code
9808572
Address
2-1, Seiryo-machi, Aoba, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
naoya.kobayashi.q4@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university graduate school of medicine, Department of anesthesia and perioperative medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
0227180461
office@nrs.hosp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036993
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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