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

Not Applicable

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: Visensia Respiration Rate Estimation Service (VRES)

• Registration Number: NCT02427828
• Lead Sponsor: OBS Medical Ltd

Brief Summary

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'.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-05
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Study First Posted: 2015-04-28
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Visensia Respiration Rate Estimation Service (VRES)	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).

Primary Outcome Measures

Name	Time	Method
Incidence of ward cardiac arrests	Up to 72hours	Duration of acute hospital stay

Trial Locations

Locations (1)

Papworth Hospital; 🇬🇧 Papworth Everard, Cambridgeshire, United Kingdom