Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: alarm management left to the discretion of the nurse, restrictive alarm use strategy.
- Who it may be relevant to
- Registry conditions: Intensive Care Unit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device alarm management left to the discretion of the nurse
alarm management left to the discretion of the nurse in charge of the patient - Device restrictive alarm use strategy
more restrictive protocol for the use of alarms
Primary outcome measures
- efficiency criterion: the number of alarms per patient per day [Time frame: 1 month]
- A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values [Time frame: 1 month]
Secondary outcome measures (4)
- Incidence of serious adverse events [Time frame: 1 month]
- Alarm response time [Time frame: 1 month]
- Evaluation of patient perception using the Discomforts of intensive care patients questionnaire [Time frame: 1 month]
- Sound level measurement using a sound level meter [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT06175091 · 20PH287 · ANSM