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Clinical Trials/NCT02427828
NCT02427828
Completed
N/A

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

OBS Medical Ltd1 site in 1 country208 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Surgical Procedure, Unspecified
Sponsor
OBS Medical Ltd
Enrollment
208
Locations
1
Primary Endpoint
Incidence of ward cardiac arrests
Status
Completed
Last Updated
11 years ago

Overview

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'.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
OBS Medical Ltd
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Incidence of ward cardiac arrests

Time Frame: Up to 72hours

Duration of acute hospital stay

Study Sites (1)

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