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

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

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:
  • conventional circuit
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:
  • Evaqua™ Breathing Circuits manufactured by Fischer & Paykel
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:
  • Mega Acer kit manufactured by Acemedical,Seoul Korea

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

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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