The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III

April 11, 2017 updated by: Philips Healthcare
To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • patients admitted to the study units during the period of data collection

Exclusion Criteria:

  • palliative patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Manual Respiration Rate Measurement
Patients with manually measured respiratory rate
Automatic Respiration Rate Measurement
Patients with automatically measured respiratory rate
Device: Automatic RR Measurement
Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of NEWS Scores
Time Frame: 8-12 Weeks
8-12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Investigators

  • Principal Investigator: Christian P Subbe, MD, Ysbyty Gwynedd Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YGB-816-VITALIII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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