- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01831843
Effect of Breathing Circuits on Intraoperative Body Temperature (BT)
September 15, 2013 updated by: Seoul National University Hospital
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 18-70 years,
- ASA I or II
- patients scheduled for craniotomy under general anesthesia
Exclusion Criteria:
- ASA III or IV
- Duration of anesthesia time less than 4 hours
- emergency operation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group C
non-heated, non-humidified conventional breathing circuit was used in group C patient
|
non-heated, non-humidified conventional breathing circuit was used in group C patient
Other Names:
|
|
Experimental: Group E
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
|
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
Other Names:
|
|
Experimental: Group M
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
|
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
trend of changes on body temperature
Time Frame: from the point of postintubation up to 5 hours
|
Investigate differences on core body temperature among different kinds of circuit (heated-humid circuit, humid circuit, conventional circuit)
|
from the point of postintubation up to 5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total duration of airwarmer(Bair-Hurgger warming unit) using time
Time Frame: from the point of postintubation up to 5hours
|
investigate the total duration of airwarmer using time
|
from the point of postintubation up to 5hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 3, 2013
First Submitted That Met QC Criteria
April 10, 2013
First Posted (Estimate)
April 15, 2013
Study Record Updates
Last Update Posted (Estimate)
September 17, 2013
Last Update Submitted That Met QC Criteria
September 15, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- php2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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