Temperature and Humidity Among Different Anesthesia Work-station (humidity)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Korea University Anam Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01193465
First received: August 30, 2010
Last updated: September 1, 2010
Last verified: July 2010
  Purpose

The effects of preserving humidity and temperature by low flow anesthesia are different in each other anesthesia workstation.


Condition Intervention Phase
Humidity
Temperature
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comparison of Heat and Humidity Conservation Among Different Anesthesia Workstation and Different Flow Rate.

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • absolute humidity at both limb of breathing circuit just distal portion of Y-piece [ Time Frame: time point 1-11 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • patient body temperature(BT) [ Time Frame: time point 1 -11 ] [ Designated as safety issue: No ]
    measure BT using esophageal temperature probe each time points are same as primary outcome

  • temperature at both limb of breathing circuit just distal portion of Y-piece [ Time Frame: time point 1- 11 ] [ Designated as safety issue: No ]
    the time points are same as primary outcome


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: humidity Device: Datex Ohmeda excel anesthesia machine
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 Name: Excel
Device: Datex Ohmeda Avance anesthesia work-station
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 Name: Avance
Device: Drager Cato anesthesia work-station
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 Name: Cato
Device: Drager Primus anesthesia work-station
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 Name: Primus

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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193465

Contacts
Contact: Seung Zhoo Yoon, Assist. P. 082-920-5632 monday1031@yahoo.co.kr
Contact: Sam Hong Min, Clin. I. 082-920-5632 neutros@naver.com

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Zhoo Yoon, Assist. P.    082-920-5632    monday1031@yahoo.co.kr   
Contact: Sam Hong Min, Clin. Inst.    082-920-5632    neutros@naver.com   
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Principal Investigator: Seung Zhoo Yoon, Assist. P. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Seung Zhoo Yoon, Department of anesthesiology and pain medicine Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01193465     History of Changes
Other Study ID Numbers: humidity
Study First Received: August 30, 2010
Last Updated: September 1, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea University Anam Hospital:
Humidity
Temperature
Low Flow Anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014