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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• efficiency criterion: the number of alarms per patient per day [Срок оценки: 1 month]
• A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values [Срок оценки: 1 month]

Вторичные конечные точки (4)

• Incidence of serious adverse events [Срок оценки: 1 month]
• Alarm response time [Срок оценки: 1 month]
• Evaluation of patient perception using the Discomforts of intensive care patients questionnaire [Срок оценки: 1 month]
• Sound level measurement using a sound level meter [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Pregnant and nursing women
• Persons of legal age under guardianship

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT06175091 · 20PH287 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗