- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193465
Temperature and Humidity Among Different Anesthesia Work-station (humidity)
September 1, 2010 updated by: Korea University Anam Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Korea University Anam Hospital
-
Contact:
- Seung Zhoo Yoon, Assist. P.
- Phone Number: 082-920-5632
- Email: monday1031@yahoo.co.kr
-
Contact:
- Sam Hong Min, Clin. Inst.
- Phone Number: 082-920-5632
- Email: neutros@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who planned more than 2 hour operation under general anesthesia
- ASA class 1,2
- blood loss less than 500ml
Exclusion Criteria:
- acute/chronic cardiac or respiratory disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: humidity
|
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
Other Names:
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
Other Names:
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
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
time point 1-11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient body temperature(BT)
Time Frame: time point 1 -11
|
measure BT using esophageal temperature probe each time points are same as primary outcome
|
time point 1 -11
|
|
temperature at both limb of breathing circuit just distal portion of Y-piece
Time Frame: time point 1- 11
|
the time points are same as primary outcome
|
time point 1- 11
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seung Zhoo Yoon, Assist. P., Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ANTICIPATED)
September 1, 2010
Study Completion (ANTICIPATED)
October 1, 2010
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
September 1, 2010
First Posted (ESTIMATE)
September 2, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2010
Last Update Submitted That Met QC Criteria
September 1, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- humidity
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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