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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040626 |
Receipt No. | R000046366 |
Scientific Title | Comparison of esCCO calibration before and after anesthesia introduction |
Date of disclosure of the study information | 2020/06/03 |
Last modified on | 2020/06/05 |
Basic information | ||
Public title | Comparison of esCCO calibration before and after anesthesia introduction | |
Acronym | Comparison of esCCO calibration before and after anesthesia introduction | |
Scientific Title | Comparison of esCCO calibration before and after anesthesia introduction | |
Scientific Title:Acronym | Comparison of esCCO calibration before and after anesthesia introduction | |
Region |
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Condition | ||
Condition | Patients who undergo general anesthesia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Which timing should esCCO be calibrated before or after anesthesia induction |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | esCCO measured before and afer anesthesia induction calibrated before anesthesia induction.
And esCCO calibrated after anesthesia induction. |
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 | |
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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 | Adult patients scheduled to undergo general anesthesia undergoing preoperative echocardiography | |||
Key exclusion criteria | 1) Patients who are recognized as "patients who have difficulty in anesthesia" defined in the medical treatment fee score table L008 in the preoperative consultation
2) Patients with the following findings of arrhythmia confirmed by preoperative consultation i) Supraventricular rhythm irregularity such as atrial fibrillation, atrial flutter, sinus arrhythmia ii) bigeminal or trigeminal pulse iii) 2nd degree AV block, 3rd degree AV block 3) Patients who need pacing during surgery 4) Patients who need repositioning during surgery 5) Patients with cardiac tamponade 6) Patients who have undergone cardiopulmonary bypass surgery 7) Patients who have undergone artificial vascular replacement surgery 8) Patients undergoing emergency surgery 9) Patients who are judged to be inappropriate for this study by the investigator |
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Target sample size | 330 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | UBE Kohsan Central Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 755-0151 | ||||||
Address | 750 Nishikiwa, Ube-shi, Yamaguchi-ken | ||||||
TEL | 0836-51-9338 | ||||||
hidaka0709@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | UBE Kohsan Central Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 755-0151 | ||||||
Address | 750 Nishikiwa, Ube-shi, Yamaguchi-ken | ||||||
TEL | 0836-51-9338 | ||||||
Homepage URL | |||||||
mby0813@gmail.com |
Sponsor | |
Institute | UBE Kohsan Central Hospital |
Institute | |
Department |
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 | UBE Kohsan Central Hospital |
Address | Department of Anesthesiology |
Tel | 0836-51-9338 |
mby0813@gmail.com |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | none |
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=R000046366 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |