Analgesia, Covid19, Critical Illness, Intensive Care Unit Delirium, Sedation Complication
Conditions
Keywords
Intensive Care Unit, Delirium, Sedation, Analgesia, COVID-19
Brief 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)
Interventions
OTHERNo intervention
No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.
Sponsors
Mount Sinai Hospital, Canada
University of Oxford
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 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 Data will not be collected from patients who fulfil the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation practice | First 7 days of mechanical ventilation | 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. |
| Use of Pain, Analgesia and Delirium assessments | First 7 days of mechanical ventilation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to PADIS guidelines | First 7 days of mechanical ventilation | 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/ |
| Sedation practice in different cohorts | First 7 days of mechanical ventilation | 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. |
| Delirium | First 7 days of mechanical ventilation | 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. |
Countries
United Kingdom
Outcome results
None listed