Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427828
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
OBS Medical Ltd

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'.


Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Device: Visensia Respiration Rate Estimation Service (VRES) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Arm Intervention/treatment
Active Comparator: 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).
Device: Visensia Respiration Rate Estimation Service (VRES)
Medical device product to provide respiration rate from PPG signal

No Intervention: 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.



Primary Outcome Measures :
  1. Incidence of ward cardiac arrests [ Time Frame: Up to 72hours ]
    Duration of acute hospital stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427828


Locations
Layout table for location information
United Kingdom
Papworth Hospital
Papworth Everard, Cambridgeshire, United Kingdom
Sponsors and Collaborators
OBS Medical Ltd
Investigators
Layout table for investigator information
Principal Investigator: John Mackay Papworth Hospital NHS Foundation Trust
Layout table for additonal information
Responsible Party: OBS Medical Ltd
ClinicalTrials.gov Identifier: NCT02427828    
Other Study ID Numbers: 011-0216-OTH
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015