Temperature and Humidity Among Different Anesthesia Work-station

Temperature Clinical Trial

— humidity  

Official title:

Comparison of Heat and Humidity Conservation Among Different Anesthesia Workstation and Different Flow Rate.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01193465
• Other study ID #: humidity
• Status: Recruiting
• Phase: Phase 4
• First received: August 30, 2010
• Last updated: September 1, 2010
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: July 2010
• Source: Korea University Anam Hospital
• Contact: Seung Zhoo Yoon, Assist. P.
• Phone: 082-920-5632
• Email: monday1031[@]yahoo.co.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Humidity
• Temperature

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time point 1-11	No
Secondary	patient body temperature(BT)	measure BT using esophageal temperature probe each time points are same as primary outcome	time point 1 -11	No
Secondary	temperature at both limb of breathing circuit just distal portion of Y-piece	the time points are same as primary outcome	time point 1- 11	No