VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU

OBS Medical

Status: Completed

Conditions: Surgical Procedure, Unspecified

Treatments: Device: Visensia Respiration Rate Estimation Service (VRES)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02427828

011-0216-OTH

Details and patient eligibility

About

Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.

Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.

More recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard).

Exclusion criteria

• transplant surgery patients,
• VAD patients,
• children (less than 18 years old),
• prisoners (due to constant observation/security may bias normal level of care),
• patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities,
• patients whose anatomy precludes the use of the required monitoring,
• patients who cannot understand written English (and where no translator is available),
• patients who are unable to give consent themselves,
• patients with learning difficulties who cannot understand the information to consent for themselves.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Treatment Group

Active Comparator group

Description:

Assessment of Visensia Respiration Rate Estimation Service (product) to provide Respiration Rate from PPG signal, providing 3 vital signs (heart rate, oxygen saturation and respiration rate) to facilitate continuous Safety Index (VSI) calculation by Visensia, alongside standard routine intermittent observations (vital signs every 4 - 6 hours).

Treatment:

Device: Visensia Respiration Rate Estimation Service (VRES)

Control Group

No Intervention group

Description:

Using standard routine intermittent observation (vital signs every 4 - 6 hours) and calculation of NEWS/MEWS scores for early detection of patient deterioration.