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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Intensive Care Unit

Treatments: Device: alarm management left to the discretion of the nurse; Device: restrictive alarm use strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06175091

20PH287

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 514 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

control group

Active Comparator group

Description:

Usual management, i.e. alarm management left to the discretion of the nurse caring for the patient.

Treatment:

Device: alarm management left to the discretion of the nurse

intervention group

Experimental group

Description:

restrictive alarm strategy

Treatment:

Device: restrictive alarm use strategy