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

Clinical Alarms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182452
• Other study ID #: PMS-BBN-EU-AA-1.00
• Status: Completed
• First received: June 8, 2017
• Last updated: April 6, 2018
• Start date: May 15, 2017
• Est. completion date: January 15, 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: 1487
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to the intensive care unit during the study period

Exclusion Criteria:

Related Conditions & MeSH terms

• Clinical Alarms

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Konstanz	Konstanz	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Alarms	Number of Different Alarms on Intensive Care	six to eight months