The Vital Signs to Identify, Target, and Assess Level (VI... | NCT02973243

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

NCT02973243

Sponsor

Philips Healthcare

Status

Completed

Last Update Posted

Apr 12, 2017Actual

Enrollment

446Actual

Phase

Not provided

Conditions

Cardiac Arrest
Renal Failure
Respiration Failure
Myocardial Infarction
Severe Sepsis

Interventions

Automatic RR Measurement

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2016Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

446Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Manual Respiration Rate Measurement		Patients with manually measured respiratory rate
Automatic Respiration Rate Measurement		Patients with automatically measured respiratory rate	Device: Automatic RR Measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Automatic RR Measurement	Device	Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.

Measure	Description	Time Frame
Number of NEWS Scores		8-12 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

palliative patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian P Subbe, MD	Ysbyty Gwynedd Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ysbyty Gwynedd Hospital		Bangor			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D051437	Renal Insufficiency
D012131	Respiratory Insufficiency
D009203	Myocardial Infarction
D018805	Sepsis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided