NCT02973243

Brief Summary

To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

November 22, 2016

Last Update Submit

April 11, 2017

Conditions

Respiration FailureCardiac ArrestRenal FailureMyocardial InfarctionSevere Sepsis

Keywords

early warning scoringrespiration rateacute care teamsNEWSCREWS

Outcome Measures

Primary Outcomes (1)

  • Number of NEWS Scores

    8-12 Weeks

Study Arms (2)

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

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.

Automatic Respiration Rate Measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • palliative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ysbyty Gwynedd Hospital

Bangor, United Kingdom

Location

MeSH Terms

Conditions

Heart ArrestRenal InsufficiencyRespiratory InsufficiencyMyocardial InfarctionSepsis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiration DisordersRespiratory Tract DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisInfectionsSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Christian P Subbe, MD

    Ysbyty Gwynedd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

October 5, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)