Clinical AssessmentCHESSNCT03448861
CHroniSense National Early Warning Score Study
A study testing Polso Wearebale watch in people with Clinical Assessment, run by BlueWind Medical.
Trial summary
ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Clinical Assessment
- What is being tested?
- Polso Wearebale watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Nov 2019
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 18 years or above
Who cannot join
- Unable or unwilling to give valid consent for participation in the study
- Known history of allergy to nylon
- Current diagnosis of sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy)
- Weak pulse
- Patients with infectious diseases requiring isolation such as Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile and Extended Spectrum Beta-Lactamases (ESBL)
- Patients with implantable defibrillators, pacemakers or neurostimulators
- Patients with Parkinson disease or essential tremor
- Patients with poor Llead I ECG signal
About this study
ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.
The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.
Read the detailed description
ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.
The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.
The parameters of the NEWS include: 1) respiratory rate pulse rate, 2) oxygen saturations, 3) body temperature; 4) systolic blood pressure, 5) heart rate, and 6) level of consciousness. Polso™ acquires, derives, and processes a number of physiological parameters. While ECG is not currently employed in NEWS, other parameters which are used in NEWS are available in the Polso™ system. In cases where manual testing is preferred for any parameter, such as use of supplemental oxygen, the individual score can be entered into the system manually. Polso™, as a wrist-based device, could enable a degree of flexibility in patient care and management.
The goal of this study is to evaluate the suitability of Polso™ as a data acquisition and processing platform capable of providing EWS summaries, against the currently employed NEWS system at the Milton Keynes University Hospital (MKUH) Cardiology Unit. The Polso™ will be employed strictly as a data-gathering system, and will not be used to influence any clinical decisions; the standard NEWS as currently employed will fulfill all its normal clinical roles.
- Conditions
- Clinical Assessment
- Being tested
- Polso Wearebale watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polso Wearebale watchDevice
The objective of the Polso™ feasibility study is to demonstrate the suitability of Polso™ as a data acquisition and processing platform by comparison with the conventional British version of EWS (UK-NEWS) on aggregate and on each individual parameter score. Although in a full NEWS system, the frequency of testing is determined by the score itself, this aspect will not be evaluated, in the event that a divergence of scores would complicate clinical evaluation and correspondence of readings. In addition, good clinical practice calls for patient care to be fully motivated by the NEWS currently in use, as opposed to the experimental Polso™. Therefore, this compromise will be made, which will still permits system evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Polso Wearable watch | Experimental | Polso Wearable watch for the purpose of NEWS measurement Receives: Device: Polso Wearebale watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
millimeters of mercury obtained by the Polso™
Measured: Through study completion, an average of 1 year
pulse rate
bpm obtained by the Polso™
Measured: Through study completion, an average of 1 year
respiratory rate
number of breaths per minute obtained by the Polso™
Measured: Through study completion, an average of 1 year
oxygen saturation
percent obtained by the Polso™
Measured: Through study completion, an average of 1 year
body temperature
Celsius temperature scale obtained by the Polso™
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical AssessmentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448861
- Sponsor's protocol ID
- CP- 090
- Acronym
- CHESS
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Velthoven MH, Adjei F, Vavoulis D, Wells G, Brindley D, Kardos A. ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design. BMJ Open. 2019 Sep 20;9(9):e028219. doi: 10.1136/bmjopen-2018-028219.
PubMed 31542738
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHroniSense National Early Warning Score Study
- ClinicalTrials.gov ID
- NCT03448861
- Acronym / sponsor ID
- CHESS / CP- 090
- Conditions
- Clinical Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.
The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.
Detailed description
ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.
The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.
The parameters of the NEWS include: 1) respiratory rate pulse rate, 2) oxygen saturations, 3) body temperature; 4) systolic blood pressure, 5) heart rate, and 6) level of consciousness. Polso™ acquires, derives, and processes a number of physiological parameters. While ECG is not currently employed in NEWS, other parameters which are used in NEWS are available in the Polso™ system. In cases where manual testing is preferred for any parameter, such as use of supplemental oxygen, the individual score can be entered into the system manually. Polso™, as a wrist-based device, could enable a degree of flexibility in patient care and management.
The goal of this study is to evaluate the suitability of Polso™ as a data acquisition and processing platform capable of providing EWS summaries, against the currently employed NEWS system at the Milton Keynes University Hospital (MKUH) Cardiology Unit. The Polso™ will be employed strictly as a data-gathering system, and will not be used to influence any clinical decisions; the standard NEWS as currently employed will fulfill all its normal clinical roles.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polso Wearable watch | Experimental | Device: Polso Wearebale watchPolso Wearable watch for the purpose of NEWS measurement |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 18 years or above
Key exclusion criteria (8 listed)
- Unable or unwilling to give valid consent for participation in the study
- Known history of allergy to nylon
- Current diagnosis of sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy)
- Weak pulse
- Patients with infectious diseases requiring isolation such as Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile and Extended Spectrum Beta-Lactamases (ESBL)
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 |
|---|---|---|
| Polso Wearebale watchThe objective of the Polso™ feasibility study is to demonstrate the suitability of Polso™ as a data acquisition and processing platform by comparison with the conventional British version of EWS (UK-NEWS) on aggregate and on each individual parameter score. Although in a full NEWS system, the frequency of testing is determined by the score itself, this aspect will not be evaluated, in the event that a divergence of scores would complicate clinical evaluation and correspondence of readings. In addition, good clinical practice calls for patient care to be fully motivated by the NEWS currently in use, as opposed to the experimental Polso™. Therefore, this compromise will be made, which will still permits system evaluation. | Device | Polso Wearable watch |
Primary outcome
blood pressure
Time frame: Through study completion, an average of 1 year
millimeters of mercury obtained by the Polso™
pulse rate
Time frame: Through study completion, an average of 1 year
bpm obtained by the Polso™
respiratory rate
Time frame: Through study completion, an average of 1 year
number of breaths per minute obtained by the Polso™
oxygen saturation
Time frame: Through study completion, an average of 1 year
percent obtained by the Polso™
body temperature
Time frame: Through study completion, an average of 1 year
Celsius temperature scale obtained by the Polso™
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 31542738Van Velthoven MH, Adjei F, Vavoulis D, Wells G, Brindley D, Kardos A. ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design. BMJ Open. 2019 Sep 20;9(9):e028219. doi: 10.1136/bmjopen-2018-028219.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Polso Wearebale watch in people with Clinical Assessment, run by BlueWind Medical.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
blood pressure (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448861, which also lists 1 linked publication.
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 24 Apr 2018.