ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

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.

Condition category

Condition code

Anaesthesiology

Anaesthetics

Cardiovascular

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]

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]

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]

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]

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]

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]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

None

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr. Sara Allen

Address [1]

Department of Cardiothoracic and ORL Anaesthesia,
Level 4, Building 32,
Auckland City Hospital,
2, Park Road,
Grafton,
Auckland 1023.

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Private Bag 92522,
Wellesley Street,
Auckland 1141

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/06/2012

Approval date [1]

26/09/2012

Ethics approval number [1]

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

Dr Alan Broderick

Address

Department of Cardiothoracic and ORL Anaesthesia, Level 4, Building 32, Auckland City Hospital, 2, Park Road, Grafton, Auckland 1023

Country

New Zealand

Phone

+64 9 307 4949

Fax

abroderick@adhb.govt.nz

Contact person for public queries

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

Phone

+64 9 307 4949

Fax

abroderick@adhb.govt.nz

Contact person for scientific queries

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

Phone

+64 9 307 4949

Fax

abroderick@adhb.govt.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically