Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000407291
Ethics application status
Approved
Date submitted
2/04/2009
Date registered
2/06/2009
Date last updated
11/11/2021
Date data sharing statement initially provided
11/11/2021
Date results information initially provided
11/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of oesophageal Doppler with arterial pressure waveform derived cardiac output and stroke volume variation for the assessment of haemodynamic state in adult patients undergoing major surgery.
Scientific title
A comparison of oesophageal Doppler with arterial pressure waveform derived cardiac output and stroke volume variation for the assessment of haemodynamic state in adult patients undergoing major surgery.
Secondary ID [1] 305777 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major surgery with significant blood loss 4560 0
Hypovolemia 4561 0
Condition category
Condition code
Anaesthesiology 4852 4852 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. This is an observational study comparing three new non-invasive cardiac output monitors. None of these monitors can act as the reference technique as neither are gold standard cardiac output monitors. However, the question is if they are interchangeable? So a comparison study will be able to see if they meausre haemodynamic events in a similar way.

In a smaller subgroup of cardiac patients, thermodilution will act as the reference. This control however will only be limited to cardiac surgery.

The observation period will start after induction of a general anaesthetic (GA) and be completed at the end of the anaesthetic. Typically a case may last 2 to 4 hours. Haemodynamic measurements will be taken at 10minutely intervals or at the same time as events. In the cardiac subgroup, there will be a further observational period of up to 2 hours in intensive care unit (ICU) whilst the patient remains intubated and sedated.

2. The oesophageal monitor will involve the insertion of a oesophageal probe under GA. It will allow continuous monitoring of cardiac ouput until it is removed before the end of the GA. The arterial pressure derived cardiac ouput (APCO) device/s will measure the cardiac ouput using the signal from a standard arterial line. Two APCO devices will be used; the Vigileo Flotrac by Edwards Lifesciences and the Lidco Rapid by Lidco.
The haemodynamic parameters generated by the monitors will be transcibed onto a spreadsheet as will clinical events such as administration of fluid, hypotension, use of vasoactive drugs, etc...
Intervention code [1] 4324 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5708 0
Accuracy of these cardiac output monitors.

This will be assessed in a number of ways.
For static error, we will use bias and variation compared to thermodilution for each of the devices. A standard representation method is Bland Altman analysis.
Timepoint [1] 5708 0
Intraoperative
Secondary outcome [1] 241623 0
Ability to track changes in cardiac output.
For dynamic error, we will use event analysis. Here, we will use mean and variation for change of cardiac ouput for an event such as fluid administration. We will subject the data to an appropriate test of statistical significance. This will enable us to determine if there is a difference in the way these machines track event changes.
Timepoint [1] 241623 0
Intraoperative

Eligibility
Key inclusion criteria
Major surgery with significant blood loss (estimated >500mls)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to an oesophageal probe such as varices or peptic ulcer disease.
Atrial Fibrillation, Aortic regurgitation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
4/09/2009
Date of last participant enrolment
Anticipated
Actual
9/10/2009
Date of last data collection
Anticipated
Actual
9/10/2009
Sample size
Target
39
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21092 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 35945 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 4749 0
Hospital
Name [1] 4749 0
Anaesthetic Department, St Vincent's Hospital
Country [1] 4749 0
Australia
Primary sponsor type
Hospital
Name
Anaesthetic Department, St Vincent's Hospital
Address
41 Victoria Pde, Fitzroy, Vic 3065
Country
Australia
Secondary sponsor category [1] 4289 0
None
Name [1] 4289 0
Address [1] 4289 0
Country [1] 4289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6791 0
St Vincent's Hospital
Ethics committee address [1] 6791 0
41 Victoria Pde, Fitzroy, Vic 3065
Ethics committee country [1] 6791 0
Australia
Date submitted for ethics approval [1] 6791 0
Approval date [1] 6791 0
30/07/2008
Ethics approval number [1] 6791 0
HREC-D 050/08

Summary
Brief summary
This study looks how accurately some monitoring systems perform during major surgery. One device looks at flow in a major artery and uses a probe inserted into the gullet under general anaesthesia. The other device/s reads a signal from a standard line inserted into a small blood vessel in your arm to record the blood pressure. The aim is to see whether these devices measure changes in blood flow accurately during surgery. As these devices are relatively new, it is important to identify wihch monitor is most accurate in helping the anaesthetic doctor to make potentially important decisions. It is an observational study and does not change your anaesthetic in a significant way.
Trial website
Trial related presentations / publications
A comparison of three minimally invasive cardiac output devices with thermodilution in elective cardiac surgery. Anaesthesia and Intensive Care 2011; Volume: 39, 6: 1014-1021: Phan T, Kluger R, Wan C, Wong D, Padayachee A.
Public notes

Contacts
Principal investigator
Name 29461 0
Dr Tuong D Phan
Address 29461 0
Department of Anaesthesia and Acute Pain Medicine
St Vincent’s Hospital Melbourne
Victoria Parade, Fitzroy, Vic 3065
Australia
Country 29461 0
Australia
Phone 29461 0
+61 3 9288 4253
Fax 29461 0
Email 29461 0
tuong.phan@svha.org.au
Contact person for public queries
Name 12708 0
Dr Tuong Phan
Address 12708 0
Anaesthetic Dept, St Vincent's Hospital
41 Victoria Pde, Vic, Fitzroy 3065
Country 12708 0
Australia
Phone 12708 0
+61 3 92882211
Fax 12708 0
+61 3 92884255
Email 12708 0
tuong.phan@svhm.org.au
Contact person for scientific queries
Name 3636 0
Dr Tuong Phan
Address 3636 0
Anaesthetic Dept, St Vincent's Hospital
41 Victoria Pde, Vic, Fitzroy 3065
Country 3636 0
Australia
Phone 3636 0
+61 3 92882211
Fax 3636 0
+61 3 92884255
Email 3636 0
tuong.phan@svhm.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not anticipated at the beginning of the trial. There are ethical considerations on making data available when it was not part of the initial consent process.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14053Informed consent form    83782-(Uploaded-25-07-2019-10-33-26)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Phan TD, Kluger R, Wan C. Minimally invasive cardi... [More Details]
Study results articleYes Phan T, Kluger R, Wan C, Wong D, Padayachee A. A ... [More Details]
Basic resultsNo 83782-(Uploaded-08-08-2021-21-50-10)-Basic results summary.docx

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMinimally invasive cardiac output monitoring: Agreement of oesophageal Doppler, LiDCOrapidTM and Vigileo FloTracTM monitors in non-cardiac surgery.2016https://dx.doi.org/10.1177/0310057x1604400313
N.B. These documents automatically identified may not have been verified by the study sponsor.