Clinical trial NCT06175091: Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
Official title: Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Unit
Keywords: alarm fatigue
nursing staff
Resuscitation patients
restrictive alarm strategy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2023-12-18
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: efficiency criterion: the number of alarms per patient per day
timeFrame: 1 month
measure: A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of serious adverse events
timeFrame: 1 month
measure: Alarm response time
timeFrame: 1 month
measure: Evaluation of patient perception using the Discomforts of intensive care patients questionnaire
timeFrame: 1 month
measure: Sound level measurement using a sound level meter
timeFrame: 7 days
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Guillaume Thiéry, PhD
role: PRINCIPAL_INVESTIGATOR
References: