Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Critical Illness Sedation Complication Intensive Care Unit Delirium Analgesia Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Main study

1\. Standard ICU arm:

* All male or female aged ≥18 years admitted to a participating Intensive Care Units who are invasively mechanically ventilated for more than 12 hours will be included.
* Patients admitted with medical, surgical, trauma, burns, neurological and neurosurgical clinical problems.
* Admitted to ICU prior to the COVID-19 surge in the specific country.

COVID-19 sub-study

1. COVID-19 ICU arm:

* All male or female aged ≥18 years admitted to a participating Intensive Care Units who are invasively mechanically ventilated for more than 12 hours will be included.
* Patients admitted with pneumonia and/or acute respiratory failure and a diagnosis of COVID-19.

* The accepted criteria for the diagnosis to COVID-19 includes one of the following: 1) RT-qPCR is positive for SARS-CoV19 nucleic acid; 2) the viral gene identified by gene sequencing; or 3) presence of COVID-19-specified IgM and IgG antibodies.
2. Non-COVID-19 ICU arm:

* All male or female aged ≥18 years admitted to a participating Intensive Care Units who are invasively mechanically ventilated for more than 12 hours will be included.
* Patients admitted with medical, surgical, trauma, burns, neurological and neurosurgical clinical problems.
* No confirmed or suspected COVID-19 disease.

Exclusion Criteria

Main study

1\. Standard ICU arm:

• Patients admitted to non-acute care units

COVID-19 sub-study

1. COVID-19 ICU arm:

* Patients with confirmed diagnosis of COVID-19 but admitted to ICU for indications different than pneumonia and/or acute respiratory failure (incidental positive COVID-19)
* Patients admitted to non-acute care units
2. Non-COVID-19 ICU arm:

* Patients admitted to non-acute care units

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No