Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02003300




Registration number
NCT02003300
Ethics application status
Date submitted
3/12/2013
Date registered
6/12/2013
Date last updated
6/12/2013

Titles & IDs
Public title
An Improved Method for the Measurement of Oxygen and Anaesthetic Agent Uptake in Patients Using the Foldes-Biro Equation
Scientific title
The Modified Foldes-Biro Equation Used in Patients Under General Anaesthesia for the Measurement of Oxygen and Anaesthetic Agent Uptake
Secondary ID [1] 0 0
GE/ASA Research Grant, 2004
Secondary ID [2] 0 0
177/03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
E03.155.197 0 0
E03.155.253 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
oxygen uptake
Timepoint [1] 0 0
During surgery

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- High risk patients (ASA 4+)

- Acute lung injury, sepsis

- Tricuspid regurgitation

- Patients under 18 years of age

- Patients unable to give informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2006
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
2004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02003300
Trial related presentations / publications
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. Erratum In: J Clin Monit Comput 1998 May;14(4):295.
Public notes

Contacts
Principal investigator
Name 0 0
Brian J Lithgow, MESc BE BSc
Address 0 0
Monash University Department of Electrical Engineering
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02003300