The Alfred
Melbourne, Victoria, 2004, Australia
Completed
NCT Number: NCT02003300
An Improved Method for the Measurement of Oxygen and Anaesthetic Agent Uptake in Patients Using the Foldes-Biro Equation
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.
Completed
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Conditions
Age range
18 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
oxygen uptake
Time frame: During surgery
Sponsors and collaborators
Lead sponsor
Bayside Health
Other Gov
Registry information
Official study title
The Modified Foldes-Biro Equation Used in Patients Under General Anaesthesia for the Measurement of Oxygen and Anaesthetic Agent Uptake
Important dates
- Study start
- 2005
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Dec 6, 2013
- Registry last updated
- Dec 6, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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