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Trial registered on ANZCTR


Registration number
ACTRN12615000621516
Ethics application status
Not yet submitted
Date submitted
7/04/2015
Date registered
16/06/2015
Date last updated
16/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
NOninvasive continuous HAemodynamic caRdiac Monitoring in vascular patients
Scientific title
Evaluating data similarity between a continuous non-invasive finger cuff device versus a continuous invasive arterial line in vascular surgery patients.
Secondary ID [1] 286470 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NO HARM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular disease 294659 0
Condition category
Condition code
Anaesthesiology 294958 294958 0 0
Other anaesthesiology
Cardiovascular 295048 295048 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves comparing the efficiency of a non-invasive finger cuff to continuously monitoring haemodynamic states in vascular patients against the current gold standard which involves an invasive arterial line.
The finger cuff device being used is the Edwards Clearsight system. This device is a non-invasive cuff that is placed on the finger tip and inflates around the finger. It is automatic and allows the operator to receive up-to-the-minute haemodynamic information on the patient. It provides blood pressure, cardiac output, stroke volume and stroke volume variation, which are all helpful parameters in predicting fluid responsiveness.
Currently, patients undergoing vascular surgery will always require the need for the invasive arterial line for continuous monitoring, and the clearsight finger cuff will additionally be used for comparision.
The devices will be used throughout the duration of the surgery, which should be at least 90 minutes in duration. It will be operated by the anaesthetist, as well as an operator will come and collect the data at the end of the surgery.
Intervention code [1] 291558 0
Treatment: Devices
Intervention code [2] 291631 0
Early detection / Screening
Comparator / control treatment
The current gold standard in continuous haemodynamic monitoring is through the use of an invasive arterial line, which all patients use when undergoing major vascular surgery.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294728 0
To compare data similarity for stroke volume variation between non-invasive finger cuff and invasive arterial line. This outcome is assessed by using both systems at the same time on the same participant and collect data at the same intervals. For the non-invasive finger cuff, the Clearsight Edwards system will be used to monitor the data, and the Edwards Flotrac will be used to collect data from the arterial line.
Timepoint [1] 294728 0
The data is to be collected every 3 minutes for the duration of the surgery from when it starts to its finish, which should be at least 90 minutes in duration.
Primary outcome [2] 294813 0
To compare data similarity for cardiac output between non-invasive finger cuff and invasive arterial line. This outcome is assessed by using both systems at the same time on the same participant and collect data at the same intervals. For the non-invasive finger cuff, the Clearsight Edwards system will be used to monitor the data, and the Edwards Flotrac will be used to collect data from the arterial line.

Timepoint [2] 294813 0
The data is to be collected every 3 minutes for the duration of the surgery from when it starts to its finish, which should be at least 90 minutes in duration.

Primary outcome [3] 294814 0
To compare data similarity for blood pressure between non-invasive finger cuff and invasive arterial line. This outcome is assessed by using both systems at the same time on the same participant and collect data at the same intervals. For the non-invasive finger cuff, the Clearsight Edwards system will be used to monitor the data, and the Edwards Flotrac will be used to collect data from the arterial line.
Timepoint [3] 294814 0
The data is to be collected every 3 minutes for the duration of the surgery from when it starts to its finish, which should be at least 90 minutes in duration.
Secondary outcome [1] 313937 0
None
Timepoint [1] 313937 0
None

Eligibility
Key inclusion criteria
- Patients undergoing the following vascular surgeries: peripheral artery revascularisation, carotid endarterectomy, open abdominal aortic aneurysm repair, endoluminal abdominal aortic aneurysm repair
- Duration of surgery 90 minutes or over
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with arrhythmia
- Patients who do not require the use of 100% mechanical ventilation
- Regional anaesthesia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly selected from Princess Alexandra hospital from theatre lists for any vascular surgery that includes peripheral artery revascularisation, carotid endarterectomy, open AAA repair and endoluminal AAA repair. All participants will be receiving both the control device and device that we are comparing it against.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We aim to sample 40 participants in this study. There is no ‘gold standard’ sample size calculation. Bland and Altman, who developed the modern approach to agreement statistics (Statistical methods for assessing agreement between two methods of clinical measurement, Bland JM, Altman DG. (1986). Lancet, i, 307-310.) have calculated sample size for agreement studies by estimating the accuracy to which the limits of agreement are measured. With a sample size of 40, the limits of agreement can be assessed to 0.48 of a standard deviation of the difference between measurements. (see http://www-users.york.ac.uk/~mb55/meas/sizemeth.htm)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3659 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 9491 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 291046 0
Commercial sector/Industry
Name [1] 291046 0
Edwards Lifesciences
Address [1] 291046 0
Global Headquarters
Edwards Lifesciences Corp
One Edwards Way
Irvine, CA 92614
Country [1] 291046 0
United States of America
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
237 Ipswich Road, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 289729 0
None
Name [1] 289729 0
Address [1] 289729 0
Country [1] 289729 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292630 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 292630 0
Princess Alexandra Hospital Centres for Health Research
Centres for Health Research Level 7 Translational Research Institute
37 Kent Street WOOLLOONGABBA QLD 4102
Ethics committee country [1] 292630 0
Australia
Date submitted for ethics approval [1] 292630 0
01/05/2015
Approval date [1] 292630 0
Ethics approval number [1] 292630 0

Summary
Brief summary
To investigate the effectiveness of the Edwards clearsight non-invasive haemodynamic monitoring in vascular patients compared to the gold standard of invasive intra-arterial monitoring. Both systems will be monitored simultaneously on the same patients, with the parameters of interest being the stroke volume variation, cardiac output, blood pressure and stroke volume.

The study design will be an interventional clinical study. Participants from Princess Alexandra Hospital will be randomly selected from surgeries that include carotid endarterectomy, peripheral artery revascularisation, open abdominal aortic aneurysm repair and endoluminal abdominal aortic aneurysm repair.

Participants will be monitored with both the Edwards clearsight system (non-invasive finger cuff) and Edwards Flotrac system (invasive intra-arterial) simultaneously and data for stroke volume variation, blood pressure, cardiac output and stroke volume will be collected from both monitoring systems. These parameters will compared and analysed
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56270 0
Dr Pal Sivalingam
Address 56270 0
Level 2, Building 1
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD, 4102
Country 56270 0
Australia
Phone 56270 0
+61 7 3176 2822
Fax 56270 0
Email 56270 0
pal.sivalingam@health.qld.gov.au
Contact person for public queries
Name 56271 0
Dr Pal Sivalingam
Address 56271 0
Level 2, Building 1
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD, 4102
Country 56271 0
Australia
Phone 56271 0
+61 7 3176 2822
Fax 56271 0
Email 56271 0
pal.sivalingam@health.qld.gov.au
Contact person for scientific queries
Name 56272 0
Dr Pal Sivalingam
Address 56272 0
Level 2, Building 1
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD, 4102
Country 56272 0
Australia
Phone 56272 0
+61 7 3176 2822
Fax 56272 0
Email 56272 0
pal.sivalingam@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results