HumidityPhase 4humidityNCT01193465
Temperature and Humidity Among Different Anesthesia Work-station
A Phase 4 study testing Datex Ohmeda excel anesthesia machine, Datex Ohmeda Avance anesthesia work-station and Drager Cato anesthesia work-station in people with Humidity and Temperature, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Humidity, Temperature
- What is being tested?
- Datex Ohmeda excel anesthesia machine, Datex Ohmeda Avance anesthesia work-station and Drager Cato anesthesia work-station
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who planned more than 2 hour operation under general anesthesia
- ASA class 1,2
- blood loss less than 500ml
Who cannot join
- acute/chronic cardiac or respiratory disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
Seung Zhoo Yoon, Assist. P., 082-920-5632, monday1031@yahoo.co.kr
Sam Hong Min, Clin. Inst., 082-920-5632, neutros@naver.com
About this study
Official title: Comparison of Heat and Humidity Conservation Among Different Anesthesia Workstation and Different Flow Rate.
The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation.
Read the detailed description
The fresh gas flow(FGF) is dry and cold in old fashioned anesthesia machine, especially at high folw (above 1 L/min). To the contrary, it has been assumed that the heat and humidity of FGF may be preserved using low FGF (below 1 L/min) during anesthesia or new anesthesia work station. However, it has not been proved yet. We hypothesized that the heat and moisture of FGF may be different in various FGF rate during anesthesia. In addition, it may be different in accordance to anesthesia work station. Therefore, we planed prospective observational study that will demonstrate that the difference of heat and moisture of FGF in different anesthesia work station (Excel; 1st generation anesthesia machine of Datex-Ohmeda Corp., Avance; 2nd generation anesthesia work station of Datex-Ohmeda Corp., Cato; 2nd generation generation anesthesia work station of Drager, Primus; 3rd generation generation anesthesia work station of Drager) and different FGF (0.5, 1, 4 L/min)
- Conditions
- Humidity, Temperature
- Being tested
- Datex Ohmeda excel anesthesia machine, Datex Ohmeda Avance anesthesia work-station, Drager Cato anesthesia work-station, Drager Primus anesthesia work-station
- Keywords
- Humidity, Temperature, Low Flow Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datex Ohmeda excel anesthesia machineDevice
Also called Excel
maintain one of following fresh gas flow, 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda excel anesthesia machine after draping complete
Datex Ohmeda Avance anesthesia work-stationDevice
Also called Avance
maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda Avance anesthesia machine after draping complete
Drager Cato anesthesia work-stationDevice
Also called Cato
maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Cato anesthesia work-station after draping complete
Drager Primus anesthesia work-stationDevice
Also called Primus
maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Primus anesthesia work-station after draping complete
| Study group | Role | What they receive |
|---|---|---|
| humidity | Experimental | Not described Receives: Device: Datex Ohmeda excel anesthesia machine; Device: Datex Ohmeda Avance anesthesia work-station; Device: Drager Cato anesthesia work-station; Device: Drager Primus anesthesia work-station |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute humidity at both limb of breathing circuit just distal portion of Y-piece
time point 1; base line value (fresh gas flow(FGF); 8L/min) time point 2; 5 mintues(min) after FGF change to predetermined level time point 3; 10 min after FGF change to predetermined level time point 4; 15 min after FGF change to predetermined level time point 5; 30 min after FGF change to predetermined level time point 6; 45 min after FGF change to predetermined level time point 7; 60 min time point 8; 75 min time point 9; 90 min time point 10; 105 min time point 11; 120 min
Measured: time point 1-11
Secondary outcomes (2)
patient body temperature(BT)
measure BT using esophageal temperature probe each time points are same as primary outcome
Measured: time point 1 -11
temperature at both limb of breathing circuit just distal portion of Y-piece
the time points are same as primary outcome
Measured: time point 1- 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HumidityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Seung Zhoo Yoon, Assist. P., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193465
- Sponsor's protocol ID
- humidity
- Acronym
- humidity
- Status last verified
- Jul 2010
- First submitted
- 30 Aug 2010
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Heat and Humidity Conservation Among Different Anesthesia Workstation and Different Flow Rate.
- ClinicalTrials.gov ID
- NCT01193465
- Acronym / sponsor ID
- humidity / humidity
- Conditions
- Humidity, Temperature
- Keywords
- Humidity, Temperature, Low Flow Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 2 Sep 2010 (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.
The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation.
Detailed description
The fresh gas flow(FGF) is dry and cold in old fashioned anesthesia machine, especially at high folw (above 1 L/min). To the contrary, it has been assumed that the heat and humidity of FGF may be preserved using low FGF (below 1 L/min) during anesthesia or new anesthesia work station. However, it has not been proved yet. We hypothesized that the heat and moisture of FGF may be different in various FGF rate during anesthesia. In addition, it may be different in accordance to anesthesia work station. Therefore, we planed prospective observational study that will demonstrate that the difference of heat and moisture of FGF in different anesthesia work station (Excel; 1st generation anesthesia machine of Datex-Ohmeda Corp., Avance; 2nd generation anesthesia work station of Datex-Ohmeda Corp., Cato; 2nd generation generation anesthesia work station of Drager, Primus; 3rd generation generation anesthesia work station of Drager) and different FGF (0.5, 1, 4 L/min)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| humidity | Experimental | Device: Datex Ohmeda excel anesthesia machine, Device: Datex Ohmeda Avance anesthesia work-station, Device: Drager Cato anesthesia work-station, Device: Drager Primus anesthesia work-station |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who planned more than 2 hour operation under general anesthesia
- ASA class 1,2
- blood loss less than 500ml
Key exclusion criteria (1 listed)
- acute/chronic cardiac or respiratory disease
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 |
|---|---|---|
| Datex Ohmeda excel anesthesia machineAlso: Excelmaintain one of following fresh gas flow, 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda excel anesthesia machine after draping complete | Device | humidity |
| Datex Ohmeda Avance anesthesia work-stationAlso: Avancemaintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda Avance anesthesia machine after draping complete | Device | humidity |
| Drager Cato anesthesia work-stationAlso: Catomaintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Cato anesthesia work-station after draping complete | Device | humidity |
| Drager Primus anesthesia work-stationAlso: Primusmaintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Primus anesthesia work-station after draping complete | Device | humidity |
Primary outcome
absolute humidity at both limb of breathing circuit just distal portion of Y-piece
Time frame: time point 1-11
time point 1; base line value (fresh gas flow(FGF); 8L/min) time point 2; 5 mintues(min) after FGF change to predetermined level time point 3; 10 min after FGF change to predetermined level time point 4; 15 min after FGF change to predetermined level time point 5; 30 min after FGF change to predetermined level time point 6; 45 min after FGF change to predetermined level time point 7; 60 min time point 8; 75 min time point 9; 90 min time point 10; 105 min time point 11; 120 min
2 secondary outcomes
patient body temperature(BT)
Time frame: time point 1 -11
temperature at both limb of breathing circuit just distal portion of Y-piece
Time frame: time point 1- 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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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.
Seung Zhoo Yoon, Assist. P. principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Datex Ohmeda excel anesthesia machine, Datex Ohmeda Avance anesthesia work-station and Drager Cato anesthesia work-station in people with Humidity and Temperature, run by Korea University Anam 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 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Zhoo Yoon, Assist. P. (082-920-5632, monday1031@yahoo.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute humidity at both limb of breathing circuit just distal portion of Y-piece (time frame: time point 1-11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2010.