Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

Study Overview
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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.

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

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

Conditions
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Critical Illness, Sedation Complication, Intensive Care Unit Delirium, Analgesia, Covid19

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Main study Data will be collected from patients who fulfil all the following inclusion criteria: 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 Data will be collected from patients who fulfil all the following inclusion criteria: 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. 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 Data will not be collected from patients who fulfil the following exclusion criteria: 1. Standard ICU arm: • Patients admitted to non-acute care units COVID-19 sub-study Data will not be collected from patients who fulfil the following exclusion criteria: 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 Non-COVID-19 ICU arm: Patients admitted to non-acute care units

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard ICU Arm (Main study)<br>We will retrospectively collect data from adults (≥18 years) admitted to a participating ICU prior to the COVID-19 surge in the country, who are invasively mechanically ventilated for more than 12 hours. We will include medical, surgical, trauma and neurological/neurosurgical patients who are COVID-19 negative. | Other: No intervention<br>* No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.<br>|
| COVID19 ICU arm (COVID-19 sub-study)<br>We will retrospectively collect data from adults (≥18 years) admitted to a participating ICU who are invasively mechanically ventilated for more than 12 hours. We will include data from patients admitted with a confirmed diagnosis of acute respiratory failure due to COVID-19 infection. | Other: No intervention<br>* No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.<br>|
| Non-COVID19 ICU arm (COVID-19 sub-study)<br>We will retrospectively collect data from adults (≥18 years) admitted to a participating ICU who are invasively mechanically ventilated for more than 12 hours. We will include data from medical, surgical, trauma and neurological/neurosurgical patients who are not admitted for COVID-19. | Other: No intervention<br>* No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation practice | Number of patient/days for each sedative and analgesic (propofol, benzodiazepines, opioids, etc.). Note: a full list of sedatives and analgesics is available in the eCRF. | First 7 days of mechanical ventilation | 
| Use of Pain, Analgesia and Delirium assessments | Number of patient/days when a Pain, Analgesia and Delirium assessment (any) has been used. Note: a list of PAD assessments is available in the eCRF. | First 7 days of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to PADIS guidelines | Percentage of patient/days with sedation, analgesia and delirium practice compliant to PADIS guidelines. Note: The full PADIS recommendations are available at https://pubmed.ncbi.nlm.nih.gov/30113371/ | First 7 days of mechanical ventilation | 
| Sedation practice in different cohorts | Number of patient/days for each sedative/analgesic drug (propofol, benzodiazepines, opioids, etc.) in different subgroups (sepsis and acute respiratory distress syndrome (ARDS), COVID-19, surgical patients, trauma and burns patients, neurocritical care patients, cardiogenic shock patients, patients receiving palliative care). Note: a full list of sedatives and analgesics is available in the eCRF. | First 7 days of mechanical ventilation | 
| Delirium | Number of patient/days when delirium was assessed (any assessment). Number of patient/days receiving treatment for delirium symptoms. Note: a full list of delirium assessments and treatment options are available in the eCRF. | First 7 days of mechanical ventilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Delirium, Sedation, Analgesia, COVID-19