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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06175091
Other study ID # 20PH287
Secondary ID ANSM
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2024
Est. completion date February 28, 2025

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Guillaume Thiéry, PhD
Phone (04)77127862
Email guillaume.thiery@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
alarm management left to the discretion of the nurse
alarm management left to the discretion of the nurse in charge of the patient
restrictive alarm use strategy
more restrictive protocol for the use of alarms

Locations

Country Name City State
France CHU de Saint-Etienne Saint-Étienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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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