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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427828
Acronym
VRES
Enrollment
208
Registered
2015-04-28
Start date
2013-03-31
Completion date
2014-07-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

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'.

Interventions

DEVICEVisensia Respiration Rate Estimation Service (VRES)

Medical device product to provide respiration rate from PPG signal

Sponsors

OBS Medical Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of ward cardiac arrestsUp to 72hoursDuration of acute hospital stay

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026