UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005378 |
|---|---|
| Receipt number | R000006385 |
| Scientific Title | An evaluation of the use of heat and moisture exchanger booster on core body temperature in patients undergoing upper abdominal surgery |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2011/04/05 14:28:14 |
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Basic information
Public title
An evaluation of the use of heat and moisture exchanger booster on core body temperature in patients undergoing upper abdominal surgery
Acronym
An evaluation of the use of HME booster on body temperature during surgery
Scientific Title
An evaluation of the use of heat and moisture exchanger booster on core body temperature in patients undergoing upper abdominal surgery
Scientific Title:Acronym
An evaluation of the use of HME booster on body temperature during surgery
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the use of HME booster preserves body temperature in patients undergoing upper abdominal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body temperature during surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patient group who receives HME booster
Interventions/Control_2
control group
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 with gastic cancer otherwise healthy
Key exclusion criteria
Patients who have severe systemic disease
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Mizutani |
Organization
Tsukuba university hospital
Division name
intensive care unit
Zip code
Address
1-1-1 tenno-dai, tsukuba, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tsukuba university hospital
Division name
department of anesthesiology
Zip code
Address
TEL
029-853-3763
Homepage URL
Sponsor or person
Institute
Tsukuba university hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
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
| 2011 | Year | 04 | Month | 05 | Day |
Last modified on
| 2011 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006385
