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

Not Applicable

• Conditions: Blood Pressure; Anaesthesiology - Other anaesthesiology; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12623001066673
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-05
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the precision of a commercially available wearable, wireless, cuffless biosensor (Biobeat BB-613P) when used via a bespoke mobile application (InteliCare Smart Platform) to measure and display blood pressure. This will be assessed by simultaneous comparison of blood pressure output with the gold standard Draeger INfinity M540 blood pressure monitor.[ Setting 1 : For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperative period up to 24 hours post-operatively];To assess the accuracy of a commercially available wearable, wireless, cuffless biosensor (Biobeat BB-613P) when used via a bespoke mobile application (InteliCare Smart Platform) to measure and display blood pressure. This will be assessed by simultaneous comparison of blood pressure output with the gold standard Draeger INfinity M540 blood pressure monitor.[ Setting 1 : For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperative period up to 24 hours post-operatively]

Secondary Outcome Measures

Name	Time	Method
Record measurements of the heart rate (HR) transmitted from the wireless device during the study period.[ Setting 1: For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperation period up to 24 hours post-operatively];Record measurements of the pulse oximetry (SpO2) transmitted from the wireless device during the study period.[ Setting 1: For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperation period up to 24 hours post-operatively];Record measurements of the temperature (T) transmitted from the wireless device during the study period.[ Setting 1: For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperation period up to 24 hours post-operatively];Record measurements of respiratory rate (RR) transmitted from the wireless device during the study period.[ Setting 1: For the duration of the cardiopulmonary exercise test<br>Setting 2: For the intraoperation period up to 24 hours post-operatively]