NCT05027217

Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

Sedation, ANalgesia and Delirium MANagement: a Study of Medical, Surgical, Trauma, and Neuro-intensive Care Patients and a COVID-19 Sub-study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,421 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with acute severe health problems often need to be admitted to specialised hospital wards called Intensive Care Units (ICUs) where they can receive emergency treatment such as mechanical ventilation to support their breathing function via a machine, and sedative medications to reduce pain and anxiety associated with the severity of their condition. Although these interventions and treatments are often necessary to support patients' vital functions, they also carry the risk of important side effects. Sedative drugs use in particular, has a significant impact on short- and long-term outcomes. Despite international guidelines to help clinicians in the use of these drugs, there appears to be large variability in their use around the world such as use of different types of drugs, variable doses or rate of continuous infusions, etc. However, even with this known variable practice across the world, there are no large-scale international studies looking at the use of sedative drugs, pain-relief medications and drugs to control agitation and restlessness in ICUs. Therefore, the investigators propose a multinational study to better understand how different ICUs use these drugs and if they follow the guidance published by expert clinicians. The investigators will collect data in more than 100 ICUs across the world and include more than 2000 adult patients admitted to ICU and needing mechanical breathing. There are no active interventions on patients that are part of this research study and data collection from patients medical records is retrospective. All patients included will receive the standard of care as per their local intensive care unit. Also, in a 2-arm sub-study, the investigators will collect retrospective data from medical records of patients admitted to ICU before and during the COVID-19 pandemic to explore how sedation, analgesia and delirium practice has changed during this exceptional timeframe.

Detailed description

Study design: Multicentre Retrospective Observational Cohort Study with two-arm COVID-19 sub-study (same design)

Conditions

• Critical Illness
• Sedation Complication
• Intensive Care Unit Delirium
• Analgesia
• Covid19

Interventions

Type	Name	Description
OTHER	No intervention	No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-05-15
• Completion: 2023-05-30
• First posted: 2021-08-30
• Last updated: 2023-06-06

Locations

1 site across 1 country: United Kingdom