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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000021570 |
Receipt No. | R000023364 |
Scientific Title | Noninvasive measurement of hemodynamic status by oscillometric method |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2018/12/26 |
Basic information | ||
Public title | Noninvasive measurement of hemodynamic status by oscillometric method | |
Acronym | Noninvasive measurement of hemodynamic status by oscillometric method | |
Scientific Title | Noninvasive measurement of hemodynamic status by oscillometric method | |
Scientific Title:Acronym | Noninvasive measurement of hemodynamic status by oscillometric method | |
Region |
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Condition | ||
Condition | Adult elective surgery patient(over 20 years old) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The validation for conventional way of the new measurement method of pulse pressure variation(PPV) and central venous pressure(CVP) |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | The estimation of error between estimated PPV and measured PPV.
The estimation of error between estimated CVP and measured CVP. |
Key secondary outcomes | Safety of our method. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Duration: During the stay in operating room.
Frequency: 12 times or more at 10 minutes or more intervals. Head down or head up of operating table. (Each maneuver performed once) |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who are planned measuring arterial pressure by arterial catheter or are planned measuring central venous pressure.
Patients who are informed enough and presents the will of participation to this study by written form. |
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Key exclusion criteria | Patients who are unsuitable for attaching the pressure cuff at both upper arms by reason of surgical procedure or physical impairment.
Patients who withdraw his informed consent. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University | ||||||
Division name | Department of Anesthesiology and Critical Care | ||||||
Zip code | |||||||
Address | 1-2-3,Kasumi,Minami-ku,Hiroshima | ||||||
TEL | 81-082-256-3234 | ||||||
anekawa@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University | ||||||
Division name | Department of Anesthesiology and Critical Care | ||||||
Zip code | |||||||
Address | 1-2-3,Kasumi,Minami-ku,Hiroshima | ||||||
TEL | 81-082-256-3234 | ||||||
Homepage URL | |||||||
r-nacamura@hiroshima-u.ac.jp |
Sponsor | |
Institute | Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | NIHON KOHDEN CORPORATION |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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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 | 広島大学病院(広島県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023364 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |