Remote Observation and Monitoring using bioSensors (ROAM – S) : Validating the Efficacy and Safety of a Remote Monitoring Devices in the Perioperative Period.

Validation of blood pressure monitoring using the Biobeat wireless chest monitor, compared to standard monitoring, in patients in the perioperative period.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12623001066673

Acronym

ROAM -S

Enrollment

Registered

2023-10-05

Start date

2023-10-05

Completion date

2023-12-29

Last updated

2023-10-09

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

Conditions

None listed

Brief summary

Clinicians and patients require means by which they can share data related to their care and in turn have steps taken to redirect care when required in real-time, before and after surgery. This data includes physiological parameters of heart rate, body temperature, blood pressure, breathing rate and oxygen saturation levels, Our vision is to co-design a digital solution aimed at providing an efficacious, safe, effective, and equitable means of communication between patients and healthcare providers during the perioperative period. The Biobeat BB-613P device, a wireless wearable chest monitor, utilises photoplethysmography (PPG) technology, and has already been used in blood pressure validation studies in both the inpatient and outpatient setting, including the ICU. However, validation for use of this device in the immediate postoperative setting on surgical wards has not been previously conducted. As the PPG technology has the unique and novel ability for cuffless blood pressure monitoring, we aim to validate the accuracy and precision of this parameter in our clinical setting, in the Cardiopulmonary Exercise laboratory and in the theatre and early post-operative setting, using the approach described by the Institute of Electronics and Electronics Engineers (IEEE) Standard 1708a™-2019.

Interventions

The Device (Biobeat BB-613P) is a non-re-usable chest biosensor (TGA approved) has a similar range of physiological parameters measured and transmitted. This is a Photo Plethysmogram (PPG) based device: the 3cm x 3cm sensor is placed on the patient’s chest (left second intercostal space) using an adhesive patch that is 5cmx5cm and will last approximately 5 days depending on the frequency of data transmission. In the Cardiopulmonary exercise test (CPET) setting (setting 1) the device will be placed on the patient just prior to the start of the test by the Study investigator or delegate. The device and adhesive will be removed after the test is completed, on the same day, by the study investigator or delegate. The CPET test involves exercising on a ergometer bike for a duration of approximately 10 minutes. During this time, recordings will be taken of blood pressure. The CPET is part of routine clinical care prior to underdoing major surgery. In the Intraoperative and immediate post operative setting (setting 2), the device will be placed on the patient just prior to the delivery of anaesthesia. It will be placed by the Study investigator or delegate. Anaesthesia will then be induced, and the operation performed as per routine. After the operation, the patient will be moved to the recovery unit. After recovery from anaesthesia is complete, the patient will be transferred to the ward. The device will be removed after 24 hours from when the patient left the recovery unit by the study investigator or delegate.

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

Setting 1: Included in the Prehabilitation Service at the PMCC with an M-DASI > 3 (modified duke activity score index) . Setting 2: Scheduled to have any surgery greater than one-hour duration with anticipated need for vasopressor drugs perioperatively and monitored in the 23-hour unit on a regular monitored schedule for 24 hours post-operatively.

Exclusion criteria

Exclusion Criteria for Setting 1: Unable to sit on an exercise bike and maintain cadence. Contra-indications to Cardiopulmonary Exercise Test (CPET) Cardiac Rhythm abnormality including the presence of AF Allergy to adhesive tapes and dressings Exclusion Criteria for Setting 2: Surgery is planned to be less than one-hour duration or greater than 4 hours duration. Planned Intensive Care or High Dependency Unit admission post-operatively Less than one overnight stay in hospital Allergy to adhesive tapes and dressings

Outcome results