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NOninvasive continuous HAemodynamic caRdiac Monitoring in vascular patients

Evaluating data similarity between a continuous non-invasive finger cuff device versus a continuous invasive arterial line in vascular surgery patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000621516
Acronym
NO HARM
Enrollment
40
Registered
2015-06-16
Start date
2015-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 pr

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.

Sponsors

Princess Alexandra Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

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

Exclusion criteria

- Patients with arrhythmia - Patients who do not require the use of 100% mechanical ventilation - Regional anaesthesia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026