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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06175091
Acronym
REALARM
Enrollment
514
Registered
2023-12-18
Start date
2024-02-08
Completion date
2028-02-28
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit

Keywords

alarm fatigue, nursing staff, Resuscitation patients, restrictive alarm strategy

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.

Interventions

DEVICEalarm management left to the discretion of the nurse

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

DEVICErestrictive alarm use strategy

more restrictive protocol for the use of alarms

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER
Ministry of Health, France
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficiency criterion: the number of alarms per patient per day1 monthAn efficiency criterion: the number of alarms per patient per day
A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values1 monthA safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values.

Secondary

MeasureTime frameDescription
Incidence of serious adverse events1 monthIncidence of serious adverse events
Alarm response time1 monthAlarm response time: the time between the alarm being triggered and the acoustic signal being silenc
Evaluation of patient perception using the Discomforts of intensive care patients questionnaire1 monthEvaluation 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.
Sound level measurement using a sound level meter7 daysSound 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.

Countries

France

Contacts

CONTACTGuillaume Thiéry, PhD
guillaume.thiery@chu-st-etienne.fr(04)77127862
CONTACTAmandine BAUDOT, CRA
amandine.baudot@chu-st-etienne.fr(0)477829450
PRINCIPAL_INVESTIGATORGuillaume Thiéry, PhD

Centre Hospitalier Universitaire de Saint Etienne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026