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NCT Number: NCT06175091

Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units

Resuscitation patients are monitored for various physiological parameters. When these parameters exceed abnormal thresholds, an audible alarm is triggered. Given the complexity of physiological situations and the number of monitored parameters, the number of alarms within an intensive care unit is significant. In the literature, the number ranges from 100 to 350 alarms per patient per day. Among these alarms, 74 to 99% are deemed irrelevant as they provide false or insignificant information. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Alice GIANNOLI

SUB_INVESTIGATOR

Eric DICONNE

SUB_INVESTIGATOR

Guillaume Thiéry, PhD

CONTACT

Isabelle MORTUREUX

SUB_INVESTIGATOR

Patricia CORREIA

SUB_INVESTIGATOR

Sophie PERINEL

SUB_INVESTIGATOR

About this study

The large volume of unnecessary alarms has multiple negative repercussions. Firstly, the excessively loud sound environment present in most resuscitation services causes stress and discomfort for both patients and caregivers. Additionally, nurses become desensitised and less responsive when the number of alarms is high, particularly if many of them are ultimately pointless. Finally, multiple interruptions of tasks associated with alarms that require responses are sources of errors in the execution of care and medication preparation.

These interruptions contribute to a phenomenon known as "alarm fatigue", which many authorsand health authorities consider a threat to patient safety.The intensive care unit of the Saint-Etienne University Hospital has had a long-standing interest in this topic, and has a computerized data collection tool that permits exhaustive analysis of all alarm signals originating from each resuscitation bed.

This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged ≥ 18 years
  • Patient admitted to the intensive care unit of the ST-ETIENNE University Hospital
  • Patient affiliated or entitled to a social security system
  • Patient having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study or, for patients who are unable to consent due to health condition, a trusted person/family member who has been informed about the study and has who has co-signed, with the investigator, a consent to participate

Exclusion criteria

  • Pregnant and nursing women
  • Persons of legal age under guardianship

Treatment and study plan

alarm management left to the discretion of the nurse

Device

alarm management left to the discretion of the nurse in charge of the patient

restrictive alarm use strategy

Device

more restrictive protocol for the use of alarms

Primary outcomes

  1. efficiency criterion: the number of alarms per patient per day

    Time frame: 1 month

    An efficiency criterion: the number of alarms per patient per day

  2. A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values

    Time frame: 1 month

    A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values.

Secondary outcomes

  1. Incidence of serious adverse events

    Time frame: 1 month

    Incidence of serious adverse events

  2. Alarm response time

    Time frame: 1 month

    Alarm response time: the time between the alarm being triggered and the acoustic signal being silenc

  3. Evaluation of patient perception using the Discomforts of intensive care patients questionnaire

    Time frame: 1 month

    Evaluation of patient perception using the Discomforts of intensive care patients questionnaire. The Discomforts of intensive care patients questionnaire validated in intensive care and in French, assesses 16 sources of discomfort, including noise. The questionnaire is given to patients before they are discharged from intensive care. The questionnaire scores range from 0 to 100, with the highest score indicating maximum discomfort.

  4. Sound level measurement using a sound level meter

    Time frame: 7 days

    Sound level measurement using a sound level meter. A measuring instrument will be placed in the rooms of the patients included during the day for 4 consecutive hours on day 1, 3 and 7. This part of the study will be carried out in conjunction with occupational medicine and the Quality, Risk Management and Patient Experience Department, which already carry out this type of measurement as part of their assessment of working conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine BAUDOT, CRA

CONTACT

[email protected]

(0)477829450 ext. +33

Guillaume Thiéry, PhD

CONTACT

[email protected]

(04)77127862 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: REALARM

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 18, 2023
Registry last updated
Mar 10, 2026

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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