Intensive Care Unit Clinical Trial
— REALARMOfficial title:
Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
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.
Status | Recruiting |
Enrollment | 514 |
Est. completion date | February 28, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficiency criterion: the number of alarms per patient per day | An efficiency criterion: the number of alarms per patient per day | 1 month | |
Primary | 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 | Incidence of serious adverse events | Incidence of serious adverse events | 1 month | |
Secondary | Alarm response time | Alarm response time: the time between the alarm being triggered and the acoustic signal being silenc | 1 month | |
Secondary | 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 | |
Secondary | 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 |
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