Outcomes and User Acceptance of the IntelliVue Alarm Advi... | NCT03347149

Studies
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)

NCT03347149

Sponsor

Philips Healthcare

Status

Completed

Last Update Posted

Apr 10, 2018Actual

Enrollment

1,336Actual

Phase

Not provided

Conditions

Clinical Alarms

Interventions

Alarm Advisor Software

Countries

United States

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 2018

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

Aug 28, 2017Actual

Primary Completion Date

Mar 11, 2018Actual

Completion Date

Mar 11, 2018Actual

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 20, 2017Actual

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 6, 2018

Last Update Posted Date

Apr 10, 2018Actual

Name	Class
Yale University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

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

This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an "Alarm Advisor software".

Detailed Description

In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

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

1,336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre-Phase (Control)		no Alarm Advisor Software installed
Post-Phase (Observation)		Alarm Advisor Software implemented	Device: Alarm Advisor Software

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alarm Advisor Software	Device	Providing advice on alarm limits as part of routine medical care	Post-Phase (Observation)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Alarms	red and yellow alarms with subgroups	2 month per phase with 2 month washout (6 month overall)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients admitted to the intensive care units during the study periods

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Not provided

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

Routinely monitored intensive care patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marjorie Funk, PhD, Professor	Yale School of Nursing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale University		New Haven	Connecticut	06516	United States

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
D000071064	Alert Fatigue, Health Personnel

Ancestor Terms

ID	Term
D005222	Mental Fatigue
D005221	Fatigue
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided