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Completed

NCT Number: NCT04994600

Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Intensive Care Units

False-positive and non-actionable alarms can lead to staff desensitization ("alarm fatigue") and thus patient endangerment. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite Universtitaetsmedizin

Berlin, 10117, Germany

About this study

In intensive care units (ICUs), patients' vital signs are monitored automatically. As soon as one of the parameters indicates a critical or potentially critical condition, an alarm is triggered on the ward. However, if there are too many alarms, even most of which are false or require no treatment, ward staff may develop alarm fatigue and become desensitized to alarms. This puts patients at risk, especially by overhearing critical alarms. Overburdening staff with alarms is part of everyday life in most ICUs. Considering the demographic development as well as the COVID-19 pandemic, it is to be expected that the number of intensive care patients and thus also the alarm burden in intensive care units will increase. This will also be exacerbated by the increasing digitization of the ICU. Evidence-based and data-driven alarm management enables clinicians to trust alarms again. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire. The questionnaire will be collected in two phases. With the data from the first phase (N ≈ 300), the investigators aim to uncover any structure that may be latent in the questionnaire data (by exploratory factor analysis) and reduce the number of questions from 27 to ~15. The reduced questionnaire will be collected in the second phase (N ≈ 300 - 400). With the data obtained, the investigators intend to test the structure postulated in the first survey in a confirmatory factor analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • physicians of German intensive care units
  • specialist nurses of German intensive care units
  • respiratory therapists of German intensive care units

Exclusion criteria

  • Refusal to participate

Treatment and study plan

Reduces number of question items

Other

The number of alarm fatigue questions are reduced to about 15 in the CFA_2nd_phase group.

Primary outcomes

  1. Rate of alarm fatigue

    Time frame: 6 months

    Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne
  • Technische Universität München, Klinik für Anästhesiologie und Intensivmedizin, Klinikum rechts der Isar Ismaninger Str. 22, 81675 München
  • Universitätsklinikum Gießen, UKGM GmbH, Justus-Liebig-Universität Gießen, Klinik für Anästhesiologie, Rudolf-Buchheim Str. 7, 35392 Gießen
  • Universitätsklinikum Heidelberg, Klinik für Anästhesiologie, Im Neuenheimer Feld 420, 69120 Heidelberg
  • Universitätsklinikum Ulm, Klinik für Anästhesiologie und Intensivmedizin, Albert-Einstein-Allee 23, 89081 Ulm
  • Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin

Registry information

Official study title

Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Nurses and Medical Doctors in Intensive Care Units

Acronym: alarmZen1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2021
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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