Clinical trial NCT02003300: An Improved Method for the Measurement of Oxygen and Anaesthetic Agent Uptake in Patients Using the Foldes-Biro Equation
Official title: The Modified Foldes-Biro Equation Used in Patients Under General Anaesthesia for the Measurement of Oxygen and Anaesthetic Agent Uptake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E03.155.197
E03.155.253
Keywords: Oxygen uptake
Anesthetic gas uptake
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2013-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

Detailed description: In a series of 30 patients undergoing cardiopulmonary bypass, the change in nitrogen concentration between fresh gas entering the anesthetic breathing system and the exhaust gas leaving it in an otherwise closed system is used to determine total gas uptake by the principle of insoluble gas dilution. Oxygen and anaesthetic agent uptakes are then automatically determined by a computer directly linked to a rapid gas analyzer, every 15 seconds.

As a control, oxygen is calculated using the reverse Fick method. Measured arterial and mixed venous oxygen saturations were used to do this, and the cardiac output which was determined by thermodilution.

Eligibility criteria: 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.

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

Primary outcomes:
measure: oxygen uptake
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
Study officials:
affiliation: Monash University Department of Electrical Engineering
name: Brian J Lithgow, MESc BE BSc
role: STUDY_DIRECTOR
affiliation: The Alfred, Bayside Health
name: Gavin JB Robinson, MB BS FANZCA
role: PRINCIPAL_INVESTIGATOR
affiliation: The Austin Hospital
name: Philip J Peyton, MB BS FANZCA
role: STUDY_DIRECTOR
References:
citation: 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.