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.

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

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 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:

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

Critically ill patients admitted to ICU and mechanically ventilated for at least 12 hours.

SANDMAN investigators will be given priority to lead secondary analyses and are encouraged to do so. Participation and authorship opportunities will be based on contribution to the primary study. The study steering committee will consider the scientific validity and the possible effect on the anonymity of participating centres prior to granting any such requests. Where necessary, a prior written agreement may be requested to set out the terms of such collaborations. Investigators should submit a secondary study proposal for review by the Executive committee. 'Cleaned' data from the international or national datasets will only be released after a secondary study proposal has been approved. An analysis involving any data derived from the SANDMAN study will be considered a secondary analysis and subject to these rules.

After the main study report is published.

Upon request to the study Executive Committee