Clinical AlarmsNCT03182452
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)
An observational study of Clinical Alarms, run by Philips Healthcare at 1 site in Germany.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Alarms
- What is being tested?
- Alarm Advisor
- How many people
- 1,487 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2017to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Monitored intensive care unit patients
Who may be able to join
- Patients admitted to the intensive care unit during the study period
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Clinical Alarms
- Being tested
- Alarm Advisor
- Keywords
- Alarms, Alarm Fatigue, Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alarm AdvisorOther
Providing advice on alarm limits as part of routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Pre Phase (no Alarm Advisor) | No Software installed | |
| Post Phase (Alarm Advisor installed) | Software implemented and staff trained (Interventional Phase) Receives: Other: Alarm Advisor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Alarms
Number of Different Alarms on Intensive Care
Measured: six to eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 May 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical AlarmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Trick, MD, Principal investigator, Klinikum Konstanz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182452
- Sponsor's protocol ID
- PMS-BBN-EU-AA-1.00
- Status last verified
- Apr 2018
- First submitted
- 8 Jun 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)
- ClinicalTrials.gov ID
- NCT03182452
- Acronym / sponsor ID
- PMS-BBN-EU-AA-1.00
- Conditions
- Clinical Alarms
- Keywords
- Alarms, Alarm Fatigue, Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,487 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Phase (no Alarm Advisor) | – | –No Software installed |
| Post Phase (Alarm Advisor installed) | – | Other: Alarm AdvisorSoftware implemented and staff trained (Interventional Phase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Monitored intensive care unit patients
Key inclusion criteria (1 listed)
- Patients admitted to the intensive care unit during the study period
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alarm AdvisorProviding advice on alarm limits as part of routine medical care | Other | Post Phase (Alarm Advisor installed) |
Primary outcome
Clinical Alarms
Time frame: six to eight months
Number of Different Alarms on Intensive Care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Trick, MD principal investigator
Klinikum Konstanz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Alarms, run by Philips Healthcare at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Alarms (time frame: six to eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.