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Effect of Breathing Circuits on Intraoperative Body Temperature (BT)

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ClinicalTrials.gov Identifier: NCT01831843
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Brain Tumor Device: Group C Device: Group E Device: Group M Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Placebo Comparator: Group C
non-heated, non-humidified conventional breathing circuit was used in group C patient
Device: Group C
non-heated, non-humidified conventional breathing circuit was used in group C patient
Other Name: 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
Device: Group E
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
Other Name: 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
Device: Group M
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Other Name: Mega Acer kit manufactured by Acemedical,Seoul Korea



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831843


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01831843     History of Changes
Other Study ID Numbers: php2
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by Seoul National University Hospital:
core body temperature
humidity
circuit temperature