Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000770864
Ethics application status
Approved
Date submitted
18/07/2012
Date registered
19/07/2012
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Date results information initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel, non-invasive device for the estimation of stroke volume compared with the continuous thermodilution technique using a pulmonary artery catheter
Scientific title
A comparison of a new, non-invasive device for the estimation of stroke volume with the continuous thermodilution technique using a pulmonary artery catheter, before and after a fluid bolus in patients undergoing cardiac surgery.
Secondary ID [1] 280866 0
Nil
Universal Trial Number (UTN)
U1111-1132-7548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who require a pulmonary artery catheter to be inserted in order to measure cardiac output as part of their anaesthetic care when undergoing cardiac surgery. 286937 0
Condition category
Condition code
Anaesthesiology 287270 287270 0 0
Anaesthetics
Cardiovascular 287284 287284 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following routine induction of anaesthesia, insertion of the usual monitoring devices (including a pulmonary artery catheter), the new device (which resembles a pulse oximeter finger probe) will be placed on one of the participant's fingers. A recording of baseline haemodynamic parameters will be made from the new device and from the pulmonary artery catheter (via the continuous thermodilution technique). Each device records automatically in an electronic manner. The pulmonary artery catheter is highly invasive (it is a line inserted in the neck passing through the heart and into the pulmonary artery of the lungs) and carries a not insignificant risk of serious complications, whereas the new device is entirely non-invasive and measures stroke volume via the variable absorbance of infrared and near-infrared lights passed through a finger tip, which poses no risk to patients. Participants will then be given a fluid bolus (7mL/kg of PlasmaLyte 148) over 7 minutes. Patients would ordinary receive a similar amount of fluid prior to commencing cardiopulmonary bypass, but usually over a period of up to 45 minutes. Two minutes following completion of the fluid bolus, the same haemodynamic recordings will be made. The study is complete at this point. The new device will be removed and the surgical procedure will continue as planned.
Intervention code [1] 285298 0
Other interventions
Comparator / control treatment
The control measurement in this case will be readings of cardiac output and stroke volume taken from a pulmonary artery catheter using the continuous thermodilution technique. The is no control treatment or control group of patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287547 0
To examine whether there is a correlation between the index of cardiac output/stroke volume (a unit-less value) as measured by the novel device and the stroke volume index as measured by the continuous thermodilution technique.
Timepoint [1] 287547 0
At completion of the second set of recordings of haemodynamic data (i.e. nine minutes per participant). All such recordings will be included in the assessment of correlation.
Primary outcome [2] 287548 0
To examine the relationship between increases in stroke volume index (continuous thermodilution technique) following a fluid bolus and increases in such indices of cardiac output/stroke volume (unit-less values) as measured by the novel device.
Timepoint [2] 287548 0
At completion of the second set of recordings of haemodynamic data (i.e. nine minutes per participant). The first set of recordings will be compared to the second set, with the participant having had a fluid bolus in between.
Secondary outcome [1] 298366 0
Nil
Timepoint [1] 298366 0
Nil

Eligibility
Key inclusion criteria
Patients due to undergo cardiac surgery.
Pulmonary artery catheter required to be inserted prior to commencement of surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal (or inability to provide full informed consent).
Ejection fraction <30% (avoids potential difficulties with giving the fluid bolus).
Cardiac arrhythmias present at induction.
Known moderate (or worse) tricuspid regurgitation (makes thermodilution estimates of CO inaccurate).
Known moderate (or worse) aortic regurgitation (previous studies using pulse contour analysis have excluded these – causes an abnormal pulse signal).
Presence of an intra-aortic balloon counterpulsation device (cause an abnormal pulse signal, device may give inaccurate readings).
Known haemoglobinopathy (novel device will not read correctly).

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
25/10/2013
Date of last participant enrolment
Anticipated
Actual
16/03/2016
Date of last data collection
Anticipated
Actual
16/03/2016
Sample size
Target
20
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 4413 0
New Zealand
State/province [1] 4413 0

Funding & Sponsors
Funding source category [1] 285652 0
Self funded/Unfunded
Name [1] 285652 0
None
Country [1] 285652 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Alan J. Broderick
Address
Department of Cardiothoracic and ORL Anaesthesia,
Level 4, Building 32,
Auckland City Hospital,
2, Park Road,
Grafton,
Auckland 1023.
Country
New Zealand
Secondary sponsor category [1] 284488 0
None
Name [1] 284488 0
Address [1] 284488 0
Country [1] 284488 0
Other collaborator category [1] 276946 0
Individual
Name [1] 276946 0
Dr. Sara Allen
Address [1] 276946 0
Department of Cardiothoracic and ORL Anaesthesia,
Level 4, Building 32,
Auckland City Hospital,
2, Park Road,
Grafton,
Auckland 1023.
Country [1] 276946 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287647 0
Northern X Regional Ethics Committee
Ethics committee address [1] 287647 0
Private Bag 92522,
Wellesley Street,
Auckland 1141
Ethics committee country [1] 287647 0
New Zealand
Date submitted for ethics approval [1] 287647 0
01/06/2012
Approval date [1] 287647 0
26/09/2012
Ethics approval number [1] 287647 0
NTX/12/06/058

Summary
Brief summary
This study will test a new device which has the potential to measure how strong patient's hearts are beating. At present it is unknown how accurate this device is. This study will compare readings from this new device with readings taken from the usual method of measuring. The usual method is to insert a special IV line (a pulmonary artery catheter) through the neck passing through the blood vessels, past the heart and into the lungs to measure how strongly the heart is beating. This requires expertise and expensive equipment. Because it is inserted through the neck it can cause complications such as bleeding, infection or a collapsed lung.

We will select 20 participants who are undergoing heart surgery at Auckland City Hospital who will be having a pulmonary artery catheter inserted as part of their standard care during their operation.

The study will take place in the operating theatre once the participant has been anaesthetised and before the surgeons begin their work. We will attach all the usual monitors we would normally use for this type of surgery. We will then attach the new device, which is similar to a pulse oximeter finger probe.

We then take a reading from the usual heart monitor (the pulmonary artery catheter) and at the same time we take a reading from the new device. We will administer some IV fluid (the standard fluid that we use for these operations) over 7 minutes. Two minutes later, we will repeat the readings. Once these readings are complete, the study has finished. The proposed surgery with then continue as normal.
We will then compare all the readings from the new device and the pulmonary artery catheter to determine how accurate the new device is, and to see if it accurate distinguish those patients who will respond to an amount of IV fluid from those who will not.
Trial website
None
Trial related presentations / publications
None to date.
Public notes

Contacts
Principal investigator
Name 34450 0
Dr Alan Broderick
Address 34450 0
Department of Cardiothoracic and ORL Anaesthesia, Level 4, Building 32, Auckland City Hospital, 2, Park Road, Grafton, Auckland 1023
Country 34450 0
New Zealand
Phone 34450 0
+64 9 307 4949
Fax 34450 0
Email 34450 0
[email protected]
Contact person for public queries
Name 17697 0
Dr Dr. Alan J. Broderick
Address 17697 0
Department of Cardiothoracic and ORL Anaesthesia,
Level 4, Building 32,
Auckland City Hospital,
2, Park Road,
Grafton,
Auckland 1023
Country 17697 0
New Zealand
Phone 17697 0
+64 9 307 4949
Fax 17697 0
Email 17697 0
[email protected]
Contact person for scientific queries
Name 8625 0
Dr Dr. Alan J. Broderick
Address 8625 0
Department of Cardiothoracic and ORL Anaesthesia,
Level 4, Building 32,
Auckland City Hospital,
2, Park Road,
Grafton,
Auckland 1023
Country 8625 0
New Zealand
Phone 8625 0
+64 9 307 4949
Fax 8625 0
Email 8625 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
Patients were not consented in advance to share data other than the final results summary which will be submitted for publication in a scientific journal.


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.