NCT01831843

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

April 3, 2013

Last Update Submit

September 15, 2013

Conditions

Keywords

core body temperaturehumiditycircuit temperature

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 COMPARATOR

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

Device: Group C

Group E

EXPERIMENTAL

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

Device: Group E

Group M

EXPERIMENTAL

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

Device: Group M

Interventions

Group CDEVICE

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

Also known as: conventional circuit
Group C
Group EDEVICE

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

Also known as: Evaqua™ Breathing Circuits manufactured by Fischer & Paykel
Group E
Group MDEVICE

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

Also known as: Mega Acer kit manufactured by Acemedical,Seoul Korea
Group M

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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

Locations