Surgical Procedure, UnspecifiedVRESNCT02427828
VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU
A study testing Visensia Respiration Rate Estimation Service (VRES) in people with Surgical Procedure, Unspecified, run by OBS Medical Ltd at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Visensia Respiration Rate Estimation Service (VRES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital
Papworth Everard, Cambridgeshire
About this study
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
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'.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Visensia Respiration Rate Estimation Service (VRES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visensia Respiration Rate Estimation Service (VRES)Device
Medical device product to provide respiration rate from PPG signal
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | 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). Receives: Device: Visensia Respiration Rate Estimation Service (VRES) |
| Control Group | No intervention | Using standard routine intermittent observation (vital signs every 4 - 6 hours) and calculation of NEWS/MEWS scores for early detection of patient deterioration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ward cardiac arrests
Duration of acute hospital stay
Measured: Up to 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- OBS Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Mackay, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427828
- Sponsor's protocol ID
- 011-0216-OTH
- Acronym
- VRES
- Status last verified
- Apr 2015
- First submitted
- 5 Nov 2013
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02427828
- Acronym / sponsor ID
- VRES / 011-0216-OTH
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- OBS Medical LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: Visensia Respiration Rate Estimation Service (VRES)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). |
| Control Group | No intervention | –Using standard routine intermittent observation (vital signs every 4 - 6 hours) and calculation of NEWS/MEWS scores for early detection of patient deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visensia Respiration Rate Estimation Service (VRES)Medical device product to provide respiration rate from PPG signal | Device | Treatment Group |
Primary outcome
Incidence of ward cardiac arrests
Time frame: Up to 72hours
Duration of acute hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mackay principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visensia Respiration Rate Estimation Service (VRES) in people with Surgical Procedure, Unspecified, run by OBS Medical Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ward cardiac arrests (time frame: Up to 72hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.