UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013707 |
|---|---|
| Receipt number | R000015959 |
| Scientific Title | The relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2015/04/11 06:15:13 |
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Basic information
Public title
The relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery
Acronym
The relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery
Scientific Title
The relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery
Scientific Title:Acronym
The relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery
Region
| Japan |
Condition
Condition
Patients aged 20 to 80 years old who has undergone elective open upper abdominal surgery are enrolled in this study.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hypothermia commonly occurs during major surgery and can be associated with perioperative complications, such as postoperative myocardial ischemia and an increased rate of surgical wound infections. Forced-air warming systems have been shown as an effective method to prevent perioperative hypothermia. We previously demonstrated that the initial temperature decrease caused by redistribution of the heat could be prevented by newly introduced warming system, Equator® convective Warmer (EQ-5000, Smith Medical). However, there was significant between-patient variability regarding to the warming efficacy of the system. The aim of the present study is to examine the relationship between body mass index and decreases in the core temperature under forced-air warming during upper abdominal surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between the core temperature of elapsed time zero and minimum temperature during surgery was defined as maximum decrease of the core temperature.
Key secondary outcomes
Blood loss (g) during surgery, Length of hospital stay (postoperative days), shivering, surgical site infection, cardiovascular events.
Base
Study type
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
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Anesthsia: All patients underwent combined epidural and general anesthesia. An epidural catheter was inserted via an interspace between Th6 and Th8 using a standard technique. Epidural anesthesia was maintained during surgery with intermittent injection of 4-10ml 0.5% ropivacaine. General anesthesia was induced using 1-2mg/kg propofol with 1-2mcg/kg fentanyl and maintained with sevofurane inhalation. Patients were paralyzed with rocuronium and mechanically ventilated. End-tidal PCO2 was maintained 35-45mmHg. All fluids administered were warmed to 40 degrees Celsius, and ambient temperature was kept near 24 degrees Celsius.
Temperature monitoring and warming methods: Pharyngeal temperature monitoring and forced-air warming was started after induction of general anesthesia. Pharyngeal temperature was measured continuously and recorded at 15-minutes intervals following induction. Forced air warming system (EquatorTM; Convective Warmer, EQ-5000, Smiths Medical, MN, USA) was used with medium temperature setting (40 degrees Celsius). Air blanket (Level 1TM; Snuggle WarmTM; Upper Body Blanket, SW 2003, Smiths Medical, MN, USA) covers the anterior extremity of patients from the over side of the body. No amino acid transfusion was used. Pre-warming was not performed.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 to 80 years old who had undergone elective open upper abdominal surgery (1) from April 1st in 2011 to March 31st in 2012 and (2) from January 15th in 2014 to January 14th in 2015 were enrolled in this study.
Key exclusion criteria
Patients were excluded if one of the following conditions existed: preoperative fasting time>12 hours, coagulopathy (prothrombin time/ international normalized ratio>1.5, activated partial thromboplastin time>one and a half as much as control, platelet count<100000/m3), thyroid disorder, neurological deficits, or history of head injury, preoperative fever, evidence of current infection, the use of vasoactive drugs during surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kato Takao |
Organization
Ichikawa General Hospital, Tokyo Dental College
Division name
Department of Anesthesiology
Zip code
Address
5-11-13, Sugano, Ichikawa-city, Chiba, Japan
TEL
047-322-0151
tkatoh@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kato Takao |
Organization
Ichikawa General Hospital, Tokyo Dental College
Division name
Department of Anesthesiology
Zip code
Address
5-11-13, Sugano, Ichikawa-city, Chiba, Japan
TEL
047-322-0151
Homepage URL
tkatoh@tdc.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Ichikawa General Hospital, Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Ichikawa General Hospital, Tokyo Dental College
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
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
| 2014 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 14 | Day |
Last modified on
| 2015 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015959
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