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

NCT ID: NCT03347149

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-03-11

Brief Summary

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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

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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.

Conditions

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Clinical Alarms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Phase (Control)

no Alarm Advisor Software installed

No interventions assigned to this group

Post-Phase (Observation)

Alarm Advisor Software implemented

Alarm Advisor Software

Intervention Type DEVICE

Providing advice on alarm limits as part of routine medical care

Interventions

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Alarm Advisor Software

Providing advice on alarm limits as part of routine medical care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marjorie Funk, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Yale School of Nursing

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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PMS-BBN-US-AA-2.01

Identifier Type: -

Identifier Source: org_study_id

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