NCT01193465

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

September 2, 2010

Status Verified

July 1, 2010

Enrollment Period

8 months

First QC Date

August 30, 2010

Last Update Submit

September 1, 2010

Conditions

Keywords

HumidityTemperatureLow Flow Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • patient body temperature(BT)

    time point 1 -11

  • temperature at both limb of breathing circuit just distal portion of Y-piece

    time point 1- 11

Study Arms (1)

humidity

EXPERIMENTAL
Device: Datex Ohmeda excel anesthesia machineDevice: Datex Ohmeda Avance anesthesia work-stationDevice: Drager Cato anesthesia work-stationDevice: Drager Primus anesthesia work-station

Interventions

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

Also known as: Excel
humidity

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

Also known as: Avance
humidity

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

Also known as: Cato
humidity

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

Also known as: Primus
humidity

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who planned more than 2 hour operation under general anesthesia
  • ASA class 1,2
  • blood loss less than 500ml

You may not qualify if:

  • acute/chronic cardiac or respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Seung Zhoo Yoon, Assist. P.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Zhoo Yoon, Assist. P.

CONTACT

Sam Hong Min, Clin. I.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 2, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

September 2, 2010

Record last verified: 2010-07

Locations