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Effect of Breathing Circuits on Intraoperative Body Temperature (BT)

Primary Purpose

Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Group C
Group E
Group M
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring core body temperature, humidity, circuit temperature

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group C

Group E

Group M

Arm Description

non-heated, non-humidified conventional breathing circuit was used in group C patient

breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient

Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient

Outcomes

Primary Outcome Measures

trend of changes on body temperature
Investigate differences on core body temperature among different kinds of circuit (heated-humid circuit, humid circuit, conventional circuit)

Secondary Outcome Measures

total duration of airwarmer(Bair-Hurgger warming unit) using time
investigate the total duration of airwarmer using time

Full Information

First Posted
April 3, 2013
Last Updated
September 15, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01831843
Brief Title
Effect of Breathing Circuits on Intraoperative Body Temperature
Acronym
BT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
core body temperature, humidity, circuit temperature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
non-heated, non-humidified conventional breathing circuit was used in group C patient
Arm Title
Group E
Arm Type
Experimental
Arm Description
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
Arm Title
Group M
Arm Type
Experimental
Arm Description
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Intervention Type
Device
Intervention Name(s)
Group C
Other Intervention Name(s)
conventional circuit
Intervention Description
non-heated, non-humidified conventional breathing circuit was used in group C patient
Intervention Type
Device
Intervention Name(s)
Group E
Other Intervention Name(s)
Evaqua™ Breathing Circuits manufactured by Fischer & Paykel
Intervention Description
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
Intervention Type
Device
Intervention Name(s)
Group M
Other Intervention Name(s)
Mega Acer kit manufactured by Acemedical,Seoul Korea
Intervention Description
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Primary Outcome Measure Information:
Title
trend of changes on body temperature
Description
Investigate differences on core body temperature among different kinds of circuit (heated-humid circuit, humid circuit, conventional circuit)
Time Frame
from the point of postintubation up to 5 hours
Secondary Outcome Measure Information:
Title
total duration of airwarmer(Bair-Hurgger warming unit) using time
Description
investigate the total duration of airwarmer using time
Time Frame
from the point of postintubation up to 5hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25771760
Citation
Kim E, Lee SY, Lim YJ, Choi JY, Jeon YT, Hwang JW, Park HP. Effect of a new heated and humidified breathing circuit with a fluid-warming device on intraoperative core temperature: a prospective randomized study. J Anesth. 2015 Aug;29(4):499-507. doi: 10.1007/s00540-015-1994-z. Epub 2015 Mar 14.
Results Reference
derived

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Effect of Breathing Circuits on Intraoperative Body Temperature

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