A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use

Официальное название

PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention

Обзор

Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.

Подробное описание

Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.

Вмешательства

• Другое Multicomponent intervention program
  Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Первичные конечные точки

• ICU-free days [Срок оценки: 28 days]

Вторичные конечные точки (12)

• Incidence rate of accidentally removed medical devices [Срок оценки: 14 days]
• Incidence rate of (self-extubation induced) reintubations [Срок оценки: 14 days]
• Days with delirium [Срок оценки: 14 days]
• Days with coma [Срок оценки: 14 days]
• Number of delirium- and coma-free days [Срок оценки: 14 days]
• Days with physical restraints [Срок оценки: 14 days]
• Days with dexmedetomidine (and total administered dose) [Срок оценки: 14 days]
• Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention [Срок оценки: 14 days]
• Days with propofol (and total administered dose) [Срок оценки: 14 days]
• Duration of mechanical ventilation in days [Срок оценки: up to 180 days]
• Hospital length of stay in days [Срок оценки: up to 180 days]
• Mortality [Срок оценки: at 28 days, 3 months and 12 months]

Критерии участия

Критерии включения

• Adult ICU patients (aged ≥18) with an expected ICU stay of >24 hours
• Patients who are (expected to become) agitated within the first 14 days of their ICU admission

Критерии исключения

• Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);
• Neurological patients with an (expected risk of) increased intracranial pressure;
• An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
• Support with Extracorporeal Membrane Oxygenation (ECMO);
• Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
• A high risk of physical aggression towards healthcare professionals;
• No consent for long term follow up in the MONITOR-IC study;
• Not able to read or understand the Dutch language and no relatives able to assist;
• Enrolment in other sedation studies.

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

Лечение

Центры проведения

Нидерланды · 5 центров

• Noordwest Ziekenhuisgroep — Alkmaar
• Bravis Ziekenhuis — Bergen op Zoom
• Amphia Ziekenhuis — Breda
• Elkerliek Ziekenhuis — Helmond
• VieCuri Medisch Centrum — Venlo

Публикации

• Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x. PMID 38082351

Идентификаторы

NCT: NCT05783505 · 2022-16133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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