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CompletedNCT03347149Updated Apr 10, 2018

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

An observational study in Clinical Alarms, sponsored by Philips Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Philips Healthcare · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,336
Ages
18 Years and older
Sex
All
01

Study 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".

Read the 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.

02

Conditions studied

  • Clinical Alarms

Keywords

  • Alarms
  • Alarm Fatigue
  • Alarm Nuisance
  • Alarm Reduction
  • Patient Monitoring
  • Intensive Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Routinely monitored intensive care patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,336 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre-Phase (Control)

    no Alarm Advisor Software installed

  • Post-Phase (Observation)

    Alarm Advisor Software implemented

    Device: Alarm Advisor Software

Interventions

  • DeviceAlarm Advisor Software

    Providing advice on alarm limits as part of routine medical care

05

What researchers measure

Primary outcomes

  1. Number of Alarms

    red and yellow alarms with subgroups

    Time frame: 2 month per phase with 2 month washout (6 month overall)

06

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06516, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03347149
Lead sponsor
Philips Healthcare
Collaborators
Yale University
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Aug 28, 2017
Primary completion
Mar 11, 2018
Completion
Mar 11, 2018
Last update
Apr 10, 2018

Study contacts

Marjorie Funk, PhD, Professor
principal investigator · Yale School of Nursing

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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