NCT02003300

Brief Summary

The primary aim is to confirm the efficacy of a new non-invasive method for measuring the oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary bypass. The method has already been successfully tested in the laboratory under controlled conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for comparison purposes, from monitoring measurements made routinely as part of normal patient care in these cases, using a pulmonary artery catheter - an invasive technique from which severe complications occasionally arise, including death. A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor, isoflurane, during this kind of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2004

Enrollment Period

1.6 years

First QC Date

December 3, 2013

Last Update Submit

December 5, 2013

Conditions

E03.155.197E03.155.253

Keywords

Oxygen uptakeAnesthetic gas uptake

Outcome Measures

Primary Outcomes (1)

  • oxygen uptake

    During surgery

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing non-emergency procedures using cardiopulmonary bypass in whom pulmonary artery catheterization was to be performed for routine monitoring purposes, including mixed venous oxygen determinations and thermodilution cardiac output determinations.

You may not qualify if:

  • High risk patients (ASA 4+)
  • Acute lung injury, sepsis
  • Tricuspid regurgitation
  • Patients under 18 years of age
  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred

Melbourne, Victoria, 2004, Australia

Location

Related Publications (1)

  • Biro P. A formula to calculate oxygen uptake during low flow anesthesia based on FIO2 measurement. J Clin Monit Comput. 1998 Feb;14(2):141-4. doi: 10.1023/a:1007413018732.

    PMID: 9669452BACKGROUND

Study Officials

  • Brian J Lithgow, MESc BE BSc

    Monash University Department of Electrical Engineering

    STUDY DIRECTOR

  • Gavin JB Robinson, MB BS FANZCA

    The Alfred, Bayside Health

    PRINCIPAL INVESTIGATOR

  • Philip J Peyton, MB BS FANZCA

    The Austin Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 6, 2013

Study Start

April 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 6, 2013

Record last verified: 2004-12

Locations

AU(1)