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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit
• Intervention / Treatment: Device: alarm management left to the discretion of the nurse; Device: restrictive alarm use strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 514
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine BAUDOT, CRA; Phone Number: +33 (0)477829450; Email: Amandine.Baudot@chu-st-etienne.fr
• Study Contact Backup: Name: Guillaume Thiéry, PhD; Phone Number: +33 (04)77127862; Email: guillaume.thiery@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Guillaume Thiéry, PhD
    • Sub-Investigator: Alice GIANNOLI
    • Sub-Investigator: Eric DICONNE
    • Sub-Investigator: Isabelle MORTUREUX
    • Sub-Investigator: Patricia CORREIA
    • Sub-Investigator: Sophie PERINEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; 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; alarm management left to the discretion of the nurse in charge of the patient
Experimental: intervention group; restrictive alarm strategy	Device: restrictive alarm use strategy; more restrictive protocol for the use of alarms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Guillaume Thiéry, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: nursing staff; alarm fatigue; Resuscitation patients; restrictive alarm strategy
• Other Study ID Numbers: 20PH287; ANSM (Other Identifier: 2023-A01346-39)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No