Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
Condition: COVID-19; ARDS; Withdrawal Syndrome; Iatrogenic Disease
MeSH terms: COVID-19; Iatrogenic Disease; Substance Withdrawal Syndrome
Study type: Observational

Summary: 
      The analgesic and sedation requirements in critically ill patients with COVID-19 have yet to
      be described. There are various factors that are likely affecting the agents being utilized
      for analgesia and sedation in these patients with little evidence to guide therapy. In
      addition, such non-evidence based practice may be leading to an increased incidence of
      iatrogenic withdrawal. The investigators seek to determine the analgesia and sedation
      requirements in critically ill patients with COVID-19 and report practice patterns that may
      be associated with iatrogenic withdrawal in these patients. The contribution of the proposed
      research will be an understanding of current analgesia and sedation use and weaning in
      critically ill patients with COVID-19, and practice patterns that may indicate the occurrence
      of iatrogenic withdrawal.

      This contribution will be significant because it will determine how analgesics and sedatives
      are being utilized in critically ill patients with COVID-19, and how their use may be leading
      to additional morbidity. Data from this initial trial will help support further research on
      the actual incidence of iatrogenic withdrawal in this patient population. Together such
      research will help inform practice patterns and therapy recommendations in advance of the
      next SARS-related outbreak.
    

Detailed description: 
      The design for this study will be an international retrospective cohort trial. The
      investigators plan to recruit multiple sites to participate in the study through the use of
      professional organization list serves and contacts from an ongoing trial being conducted by
      the investigators (i.e. ALERT-ICU), as well as direct outreach to colleagues and associates
      of members of the investigator team. Data collection will be performed retrospectively
      utilizing the electronic medical record system at each participating institution. All data
      collection will be performed using REDCap, a secure web-based data collection tool that meets
      the HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for
      protection of patient health information. Data collected will include various site and
      patient demographic data. The investigators will also collect opioid and sedative doses,
      durations of therapy, weaning of doses, and withdrawal assessments.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators anticipate involvement of 30 intensive care unit centers within the
        United States, Canada, Europe, South America, and Middle East. Each site will contribute 10
        patients who meet study criteria.
      
Keywords: Opioid Withdrawal; Benzodiazepine Withdrawal; Narcotic Withdrawal; Critically ill