Completed
BTEffect of Breathing Circuits on Intraoperative Body Temperature
What is being tested
Group C
+ Group E
+ Group M
Device
Who is being recruted
Brain Diseases+5
+ Central Nervous System Diseases
+ Neoplasms
From 18 to 70 Years
+6 Eligibility Criteria
How is the trial designed
Supportive Care Study
Placebo-Controlled
Interventional
Study Start: January 2013
Summary
Principal SponsorSeoul National University Hospital
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit
Principal SponsorSeoul National University Hospital
Last updated: September 17, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
111 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsBrain Neoplasms
Criteria
3 inclusion criteria required to participate
ASA I or II
aged 18-70 years
patients scheduled for craniotomy under general anesthesia
3 exclusion criteria prevent from participating
ASA III or IV
Duration of anesthesia time less than 4 hours
emergency operation
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Placebonon-heated, non-humidified conventional breathing circuit was used in group C patient
Group II
Experimentalbreathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
Group III
ExperimentalHeated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Seoul National University Hospital
Seoul, South KoreaOpen Seoul National University Hospital in Google MapsCompletedOne Study Center