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

NCT02427828 | Completed

• 1 other identifier: 011-0216-OTH
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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'.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

• Incidence of ward cardiac arrests

  Duration of acute hospital stay

  Up to 72hours

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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).

Device: Visensia Respiration Rate Estimation Service (VRES)

Control Group

NO INTERVENTION

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

Interventions

Visensia Respiration Rate Estimation Service (VRES) DEVICE

Medical device product to provide respiration rate from PPG signal

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• OBS Medical Ltd: lead

Study Sites (1)

Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

Location

Study Officials

• John Mackay

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: April 28, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

GB (1)