Cardiac ArrestNCT02973243
The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
An observational study of Cardiac Arrest and Renal Failure, run by Philips Healthcare at 1 site in United Kingdom.
Trial summary
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Renal Failure, Respiration Failure
- What is being tested?
- Automatic RR Measurement
- Type of treatment
- Medical device
- How many people
- 446 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2016to 28 Feb 2017
- Phase
- Observational
- 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
Study population: The investigators plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.
Who may be able to join
- patients admitted to the study units during the period of data collection
Who cannot join
- palliative patients
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.
Read the detailed description
The frequency of EWS scores, number of automated notifications and serious events performed on a general ward is contingent on the quality and frequency of vital signs measurement like respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and more frequent scoring.
We examine the influence of different respiration rate sensor concepts and measurements on scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.
- Being tested
- Automatic RR Measurement
- Keywords
- early warning scoring, respiration rate, acute care teams, NEWS, CREWS
- Medical subject headings
- Heart Arrest, Renal Insufficiency, Respiratory Insufficiency, Myocardial Infarction, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic RR MeasurementDevice
Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.
| Study group | Role | What they receive |
|---|---|---|
| Manual Respiration Rate Measurement | Patients with manually measured respiratory rate | |
| Automatic Respiration Rate Measurement | Patients with automatically measured respiratory rate Receives: Device: Automatic RR Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of NEWS Scores
Measured: 8-12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start5 Oct 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian P Subbe, MD, Principal investigator, Ysbyty Gwynedd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973243
- Sponsor's protocol ID
- YGB-816-VITALIII
- Status last verified
- Apr 2017
- First submitted
- 22 Nov 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
- ClinicalTrials.gov ID
- NCT02973243
- Acronym / sponsor ID
- YGB-816-VITALIII
- Keywords
- early warning scoring, respiration rate, acute care teams, NEWS, CREWS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 25 Nov 2016 (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.
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.
Detailed description
The frequency of EWS scores, number of automated notifications and serious events performed on a general ward is contingent on the quality and frequency of vital signs measurement like respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and more frequent scoring.
We examine the influence of different respiration rate sensor concepts and measurements on scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Respiration Rate Measurement | – | –Patients with manually measured respiratory rate |
| Automatic Respiration Rate Measurement | – | Device: Automatic RR MeasurementPatients with automatically measured respiratory rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.
Key inclusion criteria (1 listed)
- patients admitted to the study units during the period of data collection
Key exclusion criteria (1 listed)
- palliative patients
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 |
|---|---|---|
| Automatic RR MeasurementDifferent newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System. | Device | Automatic Respiration Rate Measurement |
Primary outcome
Number of NEWS Scores
Time frame: 8-12 Weeks
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 12 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Christian P Subbe, MD principal investigator
Ysbyty Gwynedd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Renal Failure, run by Philips Healthcare 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 1 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 12 Apr 2017. 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?
Number of NEWS Scores (time frame: 8-12 Weeks). 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 12 Apr 2017.