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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intensive Care Unit

Intervention / Treatment
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* Device: alarm management left to the discretion of the nurse
* Device: restrictive alarm use strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Usual management, i.e. alarm management left to the discretion of the nurse caring for the patient. | Device: alarm management left to the discretion of the nurse<br>* alarm management left to the discretion of the nurse in charge of the patient<br>|
| Experimental: intervention group<br>restrictive alarm strategy | Device: restrictive alarm use strategy<br>* more restrictive protocol for the use of alarms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficiency criterion: the number of alarms per patient per day | An efficiency criterion: the number of alarms per patient per day | 1 month | 
| A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values | A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events | Incidence of serious adverse events | 1 month | 
| Alarm response time | Alarm response time: the time between the alarm being triggered and the acoustic signal being silenc | 1 month | 
| Evaluation of patient perception using the Discomforts of intensive care patients questionnaire | 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. | 1 month | 
| Sound level measurement using a sound level meter | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alarm fatigue, nursing staff, Resuscitation patients, restrictive alarm strategy