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Accuracy of a non-invasive monitor of oxygen delivery in patients undergoing cardiac surgery

Accuracy of a non-invasive monitor of heart function and oxygen delivery during cardiac surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000650291
Enrollment
50
Registered
2009-07-31
Start date
2009-10-01
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

We have developed a unique non-invasive method to monitor oxygen levels of blood in large veins of the body and also the right side of the heart. Successful completion of this development will reduce serious complications in critically ill patients and generate cost savings for hospitals and the community by allowing valuable resources to be used more productively. This clinical trial will compare this novel device with the existing invasive technology.

Interventions

Monitoring heart function is routinely undertaken during cardiac surgery by inserting a plastic tube (pulmonary artery catheter) into a blood vessel into the neck and then advancing the plastic tube into the heart This technique can on occasion injury the heart or lungs. We have developed a novel monitor that may provide the same monitoring of heart function but without the need to insert a plastic tube into the heart (non-invasive) and therefore remove the risk or injury to the heart and lungs.

Monitoring heart function is routinely undertaken during cardiac surgery by inserting a plastic tube (pulmonary artery catheter) into a blood vessel into the neck and then advancing the plastic tube into the heart This technique can on occasion injury the heart or lungs. We have developed a novel monitor that may provide the same monitoring of heart function but without the need to insert a plastic tube into the heart (non-invasive) and therefore remove the risk or injury to the heart and lungs. We would like to assess the accuracy of this new non invasive monitor in comparison to the routine invasive method. The technique uses two distinct wavelengths of light in the infra-red range. The study will be undertaken in patients undergoing cardiac surgery. In addition to the routine invasive monitoring you will also receive non-invasive monitoring of heart function. A sensor will be placed on the skin over the heart. The sensor emits light into the heart and this provides a signal that assesses the adequacy of heart function. An ultrasound machine will be used to optimally position the sensor over the heart (these are the machines used in pregnant women to gain images of the baby). The monitoring of the heart function will continue until the patient is stable and discharged from the Intensive Care Unit. The results of the non-invasive monitor will be compared with those obtained using the routine invasive method. All patients will have invasive and non invasive monitoring. The accuracy of the non-invasive method will be compared with the invasive pulmonary artery catheter in each patient.

Sponsors

St Vincents Hospital
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

booked to have cardiac surgery

Exclusion criteria

pulmonary artery catheter not planned to be inserted as part of routine management

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026