Brain TumorBTNCT01831843
Effect of Breathing Circuits on Intraoperative Body Temperature
A study testing Group C, Group E and Group M in people with Brain Tumor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Group C, Group E and Group M
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-70 years,
- ASA I or II
- patients scheduled for craniotomy under general anesthesia
Who cannot join
- ASA III or IV
- Duration of anesthesia time less than 4 hours
- emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit
- Conditions
- Brain Tumor
- Being tested
- Group C, Group E, Group M
- Keywords
- core body temperature, humidity, circuit temperature
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CDevice
Also called conventional circuit
non-heated, non-humidified conventional breathing circuit was used in group C patient
Group EDevice
Also called Evaqua™ Breathing Circuits manufactured by Fischer & Paykel
breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer \& Paykel)was used in group E patient
Group MDevice
Also called Mega Acer kit manufactured by Acemedical,Seoul Korea
Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | non-heated, non-humidified conventional breathing circuit was used in group C patient Receives: 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 Receives: 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 Receives: Device: Group M |
What is being measured
The primary outcome is the main question the study is designed to answer.
trend of changes on body temperature
Investigate differences on core body temperature among different kinds of circuit (heated-humid circuit, humid circuit, conventional circuit)
Measured: from the point of postintubation up to 5 hours
Secondary outcomes (1)
total duration of airwarmer(Bair-Hurgger warming unit) using time
investigate the total duration of airwarmer using time
Measured: from the point of postintubation up to 5hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831843
- Sponsor's protocol ID
- php2
- Acronym
- BT
- Status last verified
- Sep 2013
- First submitted
- 3 Apr 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25771760
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Circuits on Intraoperative Body Temperature
- ClinicalTrials.gov ID
- NCT01831843
- Acronym / sponsor ID
- BT / php2
- Conditions
- Brain Tumor
- Keywords
- core body temperature, humidity, circuit temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate differences in intraoperative body temperature between heated huimid breathing circuit and conventional breathing circuit
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Device: Group Cnon-heated, non-humidified conventional breathing circuit was used in group C patient |
| Group E | Experimental | Device: Group Ebreathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer \& Paykel)was used in group E patient |
| Group M | Experimental | Device: Group MHeated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-70 years,
- ASA I or II
- patients scheduled for craniotomy under general anesthesia
Key exclusion criteria (3 listed)
- ASA III or IV
- Duration of anesthesia time less than 4 hours
- emergency operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CAlso: conventional circuitnon-heated, non-humidified conventional breathing circuit was used in group C patient | Device | Group C |
| Group EAlso: Evaqua™ Breathing Circuits manufactured by Fischer & Paykelbreathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer \& Paykel)was used in group E patient | Device | Group E |
| Group MAlso: Mega Acer kit manufactured by Acemedical,Seoul KoreaHeated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient | Device | Group M |
Primary outcome
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)
1 secondary outcome
total duration of airwarmer(Bair-Hurgger warming unit) using time
Time frame: from the point of postintubation up to 5hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 25771760Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group C, Group E and Group M in people with Brain Tumor, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trend of changes on body temperature (time frame: from the point of postintubation up to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.