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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013707
Receipt No. 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

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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
Email 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
Email tkatoh@tdc.ac.jp

Sponsor
Institute Department of Anesthesiology, Ichikawa General Hospital, Tokyo Dental College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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