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Trial registered on ANZCTR


Registration number
ACTRN12611000340932
Ethics application status
Approved
Date submitted
30/03/2011
Date registered
31/03/2011
Date last updated
24/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a measurement called pleth variability index (PVI) be used to guide clinicians in administrating fluids to patients undergoing general anaesthesia?
Scientific title
Does pleth variability index predict fluid responsiveness in mechanically ventilated patients during general anaesthesia for non-cardiac surgery?
Secondary ID [1] 259887 0
Nil
Universal Trial Number (UTN)
U1111-1120-4374
Trial acronym
PVI Fluid Responsiveness
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid responsiveness 265483 0
Condition category
Condition code
Anaesthesiology 265633 265633 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pleth variability index (PVI) is measured before and after volume expansion with 500 mL of intravenous colloid. The measurements are done before induction of general anaesthesia when a patient presents for their surgery.
Intervention code [1] 264310 0
Not applicable
Comparator / control treatment
Stroke volume index measured by oesophageal Doppler monitor in each patient simultaneously, before and after volume expansion
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262424 0
Pleth variability index (PVI) is measured with a device called Masimo Rainbow SET Pulse CO-Oximetry. Hemodynamic variables before and after volume expansion are compared using a paired t-test. Patients are allocated to 2 groups according to the percentage change in stroke volume index (SVI) measured by oesophageal Doppler monitor after volume expansion: responders are defined as change in SVI of greater or equal to 10% and non-responders as change in SVI of less than 10%. The differences between responders and non-responders were evaluated using the Student’s t-test or the Mann-Whitney U-test, as appropriate. A receiver operating characteristic (ROC) curve for PVI was generated and the optimal cut-off value was determined by the highest Youden index (calculated as: sensitivity + specificity – 1). The Spearman rank method was used to test correlation. P-values of <0.05 were considered significant.
Timepoint [1] 262424 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid
Secondary outcome [1] 273748 0
Perfusion index, derived from Masimo Rainbow SET Pulse CO-Oximetry
Timepoint [1] 273748 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid
Secondary outcome [2] 273774 0
Heart rate, derived from Masimo Rainbow SET Pulse CO-Oximetry
Timepoint [2] 273774 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid
Secondary outcome [3] 273775 0
Blood pressure, measured by a non-invasive or an invasive blood pressure monitoring device
Timepoint [3] 273775 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid
Secondary outcome [4] 273776 0
Cardiac index, derived from oesophageal Doppler monitor
Timepoint [4] 273776 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid
Secondary outcome [5] 273777 0
Corrected flow time (FTc), derived from oesophageal Doppler monitor
Timepoint [5] 273777 0
Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Eligibility
Key inclusion criteria
Non-cardiac surgical patients requiring general anaesthesia, tracheal intubation and mechanical ventilation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with arrhythmia (including atrial fibrillation), ischaemic heart disease, cardiac failure (including left and right ventricular dysfunctions), and any contraindications to oesophageal probe insertion (e.g. oesophageal varices)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
3/09/2010
Date of last participant enrolment
Anticipated
Actual
21/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264773 0
Hospital
Name [1] 264773 0
St. Vincent's Hospital
Country [1] 264773 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital
Address
Victoria Parade
Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 263888 0
None
Name [1] 263888 0
Address [1] 263888 0
Country [1] 263888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266752 0
Research Governance Unit
Ethics committee address [1] 266752 0
St. Vincent's Hospital
PO Box 2900
Fitzroy
Victoria 3065
Ethics committee country [1] 266752 0
Australia
Date submitted for ethics approval [1] 266752 0
Approval date [1] 266752 0
15/07/2010
Ethics approval number [1] 266752 0
HREC-D 057/10

Summary
Brief summary
Aim: The aim of this project is to investigate whether pleth variability index (PVI), derived from the Masimo Rainbow (Registered Trademark) SET Pulse CO-Oximetry, can predict fluid responsiveness in mechanically ventilated patients during general anaesthesia for non-cardiac surgery.
Significance: The significance of assessing PVI is that it is completely non-invasive (it only requires a probe on the finger), it provides a dynamic indicator of fluid responsiveness, and the PVI is displayed as a continuously monitored number, which makes it simple and user-friendly.
Hypothesis: The main hypothesis is that PVI can accurately and consistently predict fluid responsiveness in mechanically ventilated patients during general anaesthesia following a standard fluid challenge.
Objective: The main objective is to assess the accuracy and consistency of PVI as an indicator of assessing fluid responsiveness, when measured against the more well-established oesophageal Doppler/fluid challenge method. This will determine whether PVI can be used reliably as an indicator of fluid responsiveness.
Methods: In this observational study, a total of 30 participants will be assessed as being fluid responsive or fluid non-responsive according to stroke volume changes (measured via the minimally invasive oesophageal Doppler monitor) following the administration of a standard fluid challenge. The two main measurements including PVI and stroke volume index will be recorded along with other variables. Using appropriate statistical analysis, we will determine the consistency and accuracy of PVI in detecting fluid responsiveness.
Likely benefit of the research: The significance of assessing PVI in the current study is that it may provide a non-invasive and continuous way of determining which patients are likely to respond and thus benefit from fluid therapy, a measurement that previously requires much more invasive techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32414 0
Dr Andy Siswojo
Address 32414 0
St. Vincent's Hospital Victoria Parade Fitzroy Victoria 3065
Country 32414 0
Australia
Phone 32414 0
+613 9288 2211
Fax 32414 0
Email 32414 0
[email protected]
Contact person for public queries
Name 15661 0
Dr Andy Siswojo
Address 15661 0
St. Vincent's Hospital
Victoria Parade
Fitzroy
Victoria 3065
Country 15661 0
Australia
Phone 15661 0
+613 9288 2211
Fax 15661 0
Email 15661 0
[email protected]
Contact person for scientific queries
Name 6589 0
Dr Andy Siswojo
Address 6589 0
St. Vincent's Hospital
Victoria Parade
Fitzroy
Victoria 3065
Country 6589 0
Australia
Phone 6589 0
+613 9288 2211
Fax 6589 0
Email 6589 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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