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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant and nursing women

Persons of legal age under guardianship

Trial design

Design model

Parallel

Treatments tested in this trial

  • alarm management left to the discretion of the nurse

    Device

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

  • restrictive alarm use strategy

    Device

    more restrictive protocol for the use of alarms

Treatment groups

514 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

efficiency criterion: the number of alarms per patient per day

An efficiency criterion: the number of alarms per patient per day

Time frame
1 month
2

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.

Time frame
1 month

Secondary outcomes

1

Incidence of serious adverse events

Incidence of serious adverse events

Time frame
1 month
2

Alarm response time

Alarm response time: the time between the alarm being triggered and the acoustic signal being silenc

Time frame
1 month
3

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.

Time frame
1 month
4

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.

Time frame
7 days

Other outcomes

Sponsors and contacts

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