Intensive Care UnitREALARMNCT06175091
Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
A study testing alarm management left to the discretion of the nurse and restrictive alarm use strategy in people with Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- alarm management left to the discretion of the nurse and restrictive alarm use strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2024to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant and nursing women
- Persons of legal age under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Guillaume Thiéry, PhD
Alice GIANNOLI
About this study
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.
Read the 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.
- Conditions
- Intensive Care Unit
- Being tested
- alarm management left to the discretion of the nurse, restrictive alarm use strategy
- Keywords
- alarm fatigue, nursing staff, Resuscitation patients, restrictive alarm strategy
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alarm management left to the discretion of the nurseDevice
alarm management left to the discretion of the nurse in charge of the patient
restrictive alarm use strategyDevice
more restrictive protocol for the use of alarms
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Usual management, i.e. alarm management left to the discretion of the nurse caring for the patient. Receives: Device: alarm management left to the discretion of the nurse |
| intervention group | Experimental | restrictive alarm strategy Receives: Device: restrictive alarm use strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency criterion: the number of alarms per patient per day
An efficiency criterion: the number of alarms per patient per day
Measured: 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.
Measured: 1 month
Secondary outcomes (4)
Incidence of serious adverse events
Incidence of serious adverse events
Measured: 1 month
Alarm response time
Alarm response time: the time between the alarm being triggered and the acoustic signal being silenc
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start8 Feb 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Thiéry, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175091
- Sponsor's protocol ID
- 20PH287
- Other IDs
- ANSM
- Acronym
- REALARM
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
- ClinicalTrials.gov ID
- NCT06175091
- Acronym / sponsor ID
- REALARM / 20PH287
- Conditions
- Intensive Care Unit
- Keywords
- alarm fatigue, nursing staff, Resuscitation patients, restrictive alarm strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: alarm management left to the discretion of the nurseUsual management, i.e. alarm management left to the discretion of the nurse caring for the patient. |
| intervention group | Experimental | Device: restrictive alarm use strategyrestrictive alarm strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant and nursing women
- Persons of legal age under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alarm management left to the discretion of the nursealarm management left to the discretion of the nurse in charge of the patient | Device | control group |
| restrictive alarm use strategymore restrictive protocol for the use of alarms | Device | intervention group |
Primary outcome
efficiency criterion: the number of alarms per patient per day
Time frame: 1 month
An 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 values
Time frame: 1 month
A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Thiéry, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alarm management left to the discretion of the nurse and restrictive alarm use strategy in people with Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Thiéry, PhD ((04)77127862 ext. +33, guillaume.thiery@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency criterion: the number of alarms per patient per day (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.