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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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

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]

Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Secondary outcome [1]

Perfusion index, derived from Masimo Rainbow SET Pulse CO-Oximetry

Timepoint [1]

Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Secondary outcome [2]

Heart rate, derived from Masimo Rainbow SET Pulse CO-Oximetry

Timepoint [2]

Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Secondary outcome [3]

Blood pressure, measured by a non-invasive or an invasive blood pressure monitoring device

Timepoint [3]

Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Secondary outcome [4]

Cardiac index, derived from oesophageal Doppler monitor

Timepoint [4]

Baseline and 1 min, 2 min, and 3 min after fluid challenge, which consists of 500 mL of intravenous colloid

Secondary outcome [5]

Corrected flow time (FTc), derived from oesophageal Doppler monitor

Timepoint [5]

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]

Hospital

Name [1]

St. Vincent's Hospital

Address [1]

Victoria Parade
Fitzroy
Victoria 3065

Country [1]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital

Address

Victoria Parade
Fitzroy
Victoria 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Governance Unit

Ethics committee address [1]

St. Vincent's Hospital
PO Box 2900
Fitzroy
Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/07/2010

Ethics approval number [1]

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

Dr Andy Siswojo

Address

St. Vincent's Hospital Victoria Parade Fitzroy Victoria 3065

Country

Australia

Phone

+613 9288 2211

Fax

Email

[email protected]

Contact person for public queries

Name

Andy Siswojo

Address

St. Vincent's Hospital
Victoria Parade
Fitzroy
Victoria 3065

Country

Australia

Phone

+613 9288 2211

Fax

Email

[email protected]

Contact person for scientific queries

Name

Andy Siswojo

Address

St. Vincent's Hospital
Victoria Parade
Fitzroy
Victoria 3065

Country

Australia

Phone

+613 9288 2211

Fax

Email

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.