None listed
Conditions
Brief summary
The monitoring of blood volume status in patients requiring advanced monitoring in the operating theatres or the intensive care unit is fundamental to patient protection and treatment. However, it is currently difficult and only partly addressed by the use invasive monitoring devices. The development of new technique called peripheral intravenous volume analysis (PIVA) has recently been shown in animal experiments and dialysis patients to provide a continuous, reliable, reproducible, safe, and non-invasive assessment of blood volume state. The monitor then does mathematical modifications of the pressure waves to calculate a blood volume signal. Then it displays such information about the pressure generated by the volume of blood in the veins to the treating doctor. Finally, the monitor allows the collection of such pressure information every minute, which can then be used for detailed analysis. In this study, we simply want to connect this device to the existing drip line in a group of patients having major surgery or admitted to ICU for advanced haemodynamic monitoring. The aim of this study is to see if the PIVA monitoring delivers similar information to that which we currently obtain with more invasive, more expensive, and more complex technology. Moreover, we aim to ask clinicians whether easy to use; and achieves the reliable delivery of good quality data. Finally, we wish to see if all these aspects of PIVA prove correct, as we will then seek approval to conduct further and more advances studies of PIVA.
Interventions
This study will use the medical 'peripheral intraVenous waveform analysis' (PIVA) device with its intravenous line with sensor for the procedure. A peripheral intravenous line is routinely placed as part of the clinical care. The PIVA intravenous line with sensor will be connected to the PIVA monitor. PIVA signals will be obtained and stored in the monitor for subsequent analysis. PIVA data will not be used to inform patient treatment. A member of the investigating team will ensure that the PIV
This study will use the medical 'peripheral intraVenous waveform analysis' (PIVA) device with its intravenous line with sensor for the procedure. A peripheral intravenous line is routinely placed as part of the clinical care. The PIVA intravenous line with sensor will be connected to the PIVA monitor. PIVA signals will be obtained and stored in the monitor for subsequent analysis. PIVA data will not be used to inform patient treatment. A member of the investigating team will ensure that the PIVA device is set-up and running correctly. Treating clinicians will be provided with a bedside tutorial on the device and asked to continue to provide routine care. Clinical and physiological parameters will be recorded in their routine fashion by clinical staff, this will include the administration of fluid therapy or the use of vasoactive medicines or mechanical ventilation. Clinical information will then be retrieved retrospectively from the patients medical record by a member of the investigating team.
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
adult aged equal to or older than 18 years expected to under go surgery with invasive haemodynamic monitoring expected to admitted to the intensive care unit and receiving haemodynamic montoring
Exclusion criteria
No invasive hemodynamic monitoring planned No invasive hemodynamic monitoring present No peripheral venous catheter present Female patients who are pregnant or lactating Active irregular heart rhythm Congenital heart disease Restrictive cardiomyopathy (e.g. due to amyloidosis) Severe mitral stenosis, moderate or severe aortic stenosis, or mitral or aortic valve replacement Extracorporeal circulation (e.g. cardiopulmonary bypass, LVAD, ECMO, or active dialysis during measurement) Dual lung ventilation Use of vasopressors, starches, lipids (including propofol), or dextrose solutions greater than 5% concentration through the IV line.
Outcome results
None listed