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Clinical Trial 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, we propose a multinational study to better understand how different ICUs use these drugs and if they follow the guidance published by expert clinicians. We 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, we 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.

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

NCT number NCT05027217
Study type Observational
Source University of Oxford
Contact Lara Prisco, Dr
Phone 00447901192056
Email [email protected]
Status Not yet recruiting
Start date September 1, 2021
Completion date January 1, 2022

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