Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000899145
Ethics application status
Approved
Date submitted
7/06/2019
Date registered
26/06/2019
Date last updated
15/09/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of peripheral intravenous volume analysis in patients receiving haemodynamic monitoring
Scientific title
A prospective study of venous waveform-derived volume status via peripheral intravenous volume analysis in patients receiving invasive haemodynamic monitoring
Secondary ID [1] 298498 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular instability 313185 0
Condition category
Condition code
Cardiovascular 311647 311647 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314691 0
Treatment: Devices
Comparator / control treatment
Patients are their own controls and the PIVA-derived data will be compared to standard haemodynamic parameters routinely collected for hospitalised patients.
Control group
Active

Outcomes
Primary outcome [1] 320352 0
Change in blood pressure derived from the PIVA sensor
Timepoint [1] 320352 0
Changes in the venous waveform assessment of volume status from baseline over a minimum period of 2 hours
Secondary outcome [1] 371315 0
Ease of PIVA use
Timepoint [1] 371315 0
Questionnaire to be completed by bedside staff after a minimum of 2 hours use with a determination of 'strongly disagree/disagree/neutral/agree/strongly agree being recorded
Secondary outcome [2] 371726 0
Difficulty to use PIVA
Timepoint [2] 371726 0
Questionnaire to be completed by bedside staff after a minimum of 2 hours use with a determination of 'strongly disagree/disagree/neutral/agree/strongly agree being recorded
Secondary outcome [3] 371727 0
Assessment of difficultly to obtain good quality data while monitoring with the PIVA device
Timepoint [3] 371727 0
Questionnaire to be completed by bedside staff after a minimum of 2 hours use with a determination of 'strongly disagree/disagree/neutral/agree/strongly agree being recorded
Secondary outcome [4] 371989 0
Change in fluid balance occurring over the first 2 hours of PIVA monitoring period
Timepoint [4] 371989 0
Changes in the fluid balance state from baseline over a minimum period of 2 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
First, we will use descriptive statistics to characterize the patients as has been done for other techniques). Then, we will describe the cohort specific PIVA measurements (normal range among euvolemic pre-surgery patients in this study, effect of fluid administration on PIVA, and association of PIVA with fluid removal by diuretics group and overall fluid balance). Then, we will evaluate the relationship between PIVA derived data with the following markers of intravascular volume status: arterial blood pressure; central venous pressure (if available); cardiac index (if available); pulse pressure variation (if available); stroke volume variation (if available); pulmonary artery pressure (if available), and fluid balance (output minus input)

To describe the patients, we will use means and standard deviations, medians and interquartile ranges, or counts and percentages as appropriate. Then, we will characterize the distribution of PIVA values at baseline. Beyond visual characterization using a histogram, we will estimate parameters of the distribution, including the mean, standard deviation and percentiles. We will use the family of generalized linear models with a linear link function to model PIVA as a function of time, we will ensure the covariance estimates take into account the repeated within-patient measurements. We will consider the possibility that the relationship with time is non-linear. If we find a systematic effect of time on PIVA among euvolemic subjects at rest, this will be informative for establishing normative values as well as for interpreting subsequent analyses. Secondary to ascertaining whether there is systematic variation, we will estimate the random within-subject variation. Finally, we will include age and comorbidity in the model to determine whether they affect the absolute PIVA values and the variation in PIVA values within subjects. If there are significant effects of age or comorbidities, separate normal ranges may be provided for these groups.

During treatment, we will include either fluids administered (for the hypovolemic group model) or measures of fluid loss (for the hypervolemic group model) as the primary predictor. As before, we will model PIVA as a function of fluids taking into account the repeated within-patient measurements. We will consider the possibility that the relationship is non-linear. We expect to find a systematic association between fluids and PIVA that can be used for establishing the normal response of persons to either fluid administration or fluid loss. We will include age, comorbidity and baseline PIVA values in the model to determine whether they affect the change in PIVA values. We will also evaluate the effect of vasopressors on PIVA values and on the change in PIVA with fluid administration. To compare the changes in PIVA (delta-PIVA) to the changes in other hemodynamic measurements we will evaluate the correlation between scores as a gross characterization of association within each cohort. Then, we will model PIVA as a function of changes in cardiac index, arterial blood pressure, central venous pressure, pulse pressure variation, stroke volume variation and pulmonary pressure variation (as available) taking into account baseline values. Finally, we will compare the repeatability of delta PIVA to that in the above measures by comparing standardized limits of agreement. In addition to modelling approaches above, we will explore other associations of interest. Bivariate methods (such as difference tests and cross tabulations) will be used as exploratory investigations. We do not plan to adjust such analyses for multiplicity as they are hypothesis generating, not hypothesis testing. All analyses will be interpreted recognizing the possibility of false positive findings. The strength of evidence will be tempered by biological plausibility and patterns of association. The results of these exploratory analyses may inform the generation of previously specified models, but we are not using a stepwise modelling approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13967 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26804 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302994 0
Commercial sector/Industry
Name [1] 302994 0
Baxter Healthcare Corporation
Country [1] 302994 0
United States of America
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg, Victoria
Australia 3084
Country
Australia
Secondary sponsor category [1] 302955 0
Individual
Name [1] 302955 0
Professor Rinaldo Bellomo
Address [1] 302955 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria
Australia 3084
Country [1] 302955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303543 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303543 0
145 Studley Road
Heidelberg, Victoria
Australia 3084
Ethics committee country [1] 303543 0
Australia
Date submitted for ethics approval [1] 303543 0
18/10/2018
Approval date [1] 303543 0
14/12/2018
Ethics approval number [1] 303543 0
HREC/47900/Austin-2018

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94030 0
Prof Rinaldo Bellomo
Address 94030 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Australia
Country 94030 0
Australia
Phone 94030 0
+61394965992
Fax 94030 0
+61394963932
Email 94030 0
[email protected]
Contact person for public queries
Name 94031 0
Dr Glenn Eastwood
Address 94031 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Australia
Country 94031 0
Australia
Phone 94031 0
+61394964835
Fax 94031 0
+61394963932
Email 94031 0
[email protected]
Contact person for scientific queries
Name 94032 0
Prof Rinaldo Bellomo
Address 94032 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Australia
Country 94032 0
Australia
Phone 94032 0
+61394965992
Fax 94032 0
+61394963932
Email 94032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Will depending on commerical in confidence with Baxter Healthcare


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2290Study protocol    377743-(Uploaded-14-06-2019-12-43-29)-Study-related document.docx



Results publications and other study-related documents

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