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

Surgical Procedure, Unspecified Clinical Trial

— VRES  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427828
• Other study ID #: 011-0216-OTH
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: April 27, 2015
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: OBS Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• Visensia Respiration Rate Estimation Service (VRES)
Medical device product to provide respiration rate from PPG signal

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Papworth Everard	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
OBS Medical Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ward cardiac arrests	Duration of acute hospital stay	Up to 72hours	No