NCT03182452

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

June 8, 2017

Last Update Submit

April 6, 2018

Conditions

Clinical Alarms

Keywords

AlarmsAlarm FatigueAlarm NuisanceAlarm ReductionPatient MonitoringIntensive Care

Outcome Measures

Primary Outcomes (1)

  • Clinical Alarms

    Number of Different Alarms on Intensive Care

    six to eight months

Study Arms (2)

Pre Phase (no Alarm Advisor)

No Software installed

Post Phase (Alarm Advisor installed)

Software implemented and staff trained (Interventional Phase)

Other: Alarm Advisor

Interventions

Alarm AdvisorOTHER

Providing advice on alarm limits as part of routine medical care

Post Phase (Alarm Advisor installed)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Monitored intensive care unit patients

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Michael Trick, MD

    Klinikum Konstanz, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 9, 2017

Study Start

May 15, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

April 9, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)