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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-07-31

Brief Summary

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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'.

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Detailed Description

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Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Group

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).

Group Type ACTIVE_COMPARATOR

Visensia Respiration Rate Estimation Service (VRES)

Intervention Type DEVICE

Medical device product to provide respiration rate from PPG signal

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visensia Respiration Rate Estimation Service (VRES)

Medical device product to provide respiration rate from PPG signal

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No