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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016802 |
Receipt No. | R000019501 |
Scientific Title | Evaluation of a newly developed monitor of deep body temperature other than the forehead in the perioperative period |
Date of disclosure of the study information | 2015/03/15 |
Last modified on | 2020/05/19 |
Basic information | ||
Public title | Evaluation of a newly developed monitor of deep body temperature other than the forehead in the perioperative period | |
Acronym | monitoring of deep body temperature | |
Scientific Title | Evaluation of a newly developed monitor of deep body temperature other than the forehead in the perioperative period | |
Scientific Title:Acronym | monitoring of deep body temperature | |
Region |
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Condition | ||
Condition | general anesthesia patients | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Recently, equipment used for deep temperature monitoring has been improved with release of a new instrument (Spot OnTM; 3M, St. Paul, MN). We therefore evaluated the temperature data obtained from other than the forehead in comparison with esophageal, tympanic and pulmonary artery temperatures during general anesthesia.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Evaluation of a newly developed monitor of deep body temperature in comparison with others. |
Key secondary outcomes | Observation of adverse events during using deep tempreture monitor. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | cases under general anesthesia | |||
Key exclusion criteria | forehead skin abnomarlity | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo Medical University | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 0600543 | ||||||
Address | minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo | ||||||
TEL | 011-611-2111 | ||||||
yamakage@sapmed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo Medical University | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 0600543 | ||||||
Address | minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo | ||||||
TEL | 011-611-2111 | ||||||
Homepage URL | |||||||
tachibana@sapmed.ac.jp |
Sponsor | |
Institute | Department of Anesthesiology,Sapporo Medical University,School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Anesthesiology,Sapporo Medical University,School of Medicine |
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 | Sapporo Medical University IRB |
Address | minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo |
Tel | 011-611-2111 |
tachibana@sapmed.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 | 札幌医科大学附属病院(北海道),Sapporo Medical University(Hokkaido) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | In casese of non cardicac operations,after induction of general anesthesia,we set deep body teperature monitor except forehead (ex.neck or chest) and measure esophageal,tympanic temperature.
In casese of cardicac operations,after induction of general anesthesia,we set deep body teperature monitor except forehead (ex.neck or chest) and measure esophageal,tympanic,pulmonary artery temperature. The temperature data were collected and statistically analyzed. |
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=R000019501 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
Registered date | File name |