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

Clinical Alarms Clinical Trial

Official title:

Nurses' Customization of Physiologic Monitor Alarms: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347149
• Other study ID #: PMS-BBN-US-AA-2.01
• Status: Completed
• First received: November 13, 2017
• Last updated: April 6, 2018
• Start date: August 28, 2017
• Est. completion date: March 11, 2018

Study information

• Verified date: April 2018
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1336
• Est. completion date: March 11, 2018
• Est. primary completion date: March 11, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Clinical Alarms

Intervention

Device:
• Alarm Advisor Software
Providing advice on alarm limits as part of routine medical care

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Philips Healthcare	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Alarms	red and yellow alarms with subgroups	2 month per phase with 2 month washout (6 month overall)