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Completed

NCT Number: NCT02427828

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

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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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visensia Respiration Rate Estimation Service (VRES)

Device

Medical device product to provide respiration rate from PPG signal

Primary outcomes

  1. Incidence of ward cardiac arrests

    Time frame: Up to 72hours

    Duration of acute hospital stay

Sponsors and collaborators

Lead sponsor

OBS Medical Ltd

Industry

Registry information

Official study title

Continuous, Ambulatory, Non Invasive, Vital Sign Monitoring Using VRES of Cardiac Surgical Patients Following Discharge From Intensive Care. Impact on Detection of Physiological Deterioration

Acronym: VRES

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2015
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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