Effect of Breathing Circuits on Intraoperative Body Temperature
BT
1 other identifier
interventional
111
1 country
1
Brief Summary
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 3, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedSeptember 17, 2013
September 1, 2013
6 months
April 3, 2013
September 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
trend of changes on body temperature
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 Outcomes (1)
total duration of airwarmer(Bair-Hurgger warming unit) using time
from the point of postintubation up to 5hours
Study Arms (3)
Group C
PLACEBO COMPARATORnon-heated, non-humidified conventional breathing circuit was used in group C patient
Group E
EXPERIMENTALbreathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer \& Paykel)was used in group E patient
Group M
EXPERIMENTALHeated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Interventions
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
Eligibility Criteria
You may qualify if:
- aged 18-70 years,
- ASA I or II
- patients scheduled for craniotomy under general anesthesia
You may not qualify if:
- ASA III or IV
- Duration of anesthesia time less than 4 hours
- emergency operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, South Korea
Related Publications (1)
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.
PMID: 25771760DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2013
First Posted
April 15, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
September 17, 2013
Record last verified: 2013-09