Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit (SAnDMAN)

University of Oxford

Status: Completed

Conditions: Sedation Complication; Critical Illness; Covid19; Analgesia; Intensive Care Unit Delirium

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05027217

PID15072

Trials Group Award 2018 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3,421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

3,421 participants in 3 patient groups

Standard ICU Arm (Main study)

Description:

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.

Treatment:

Other: No intervention

COVID19 ICU arm (COVID-19 sub-study)

Description:

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.

Treatment:

Other: No intervention

Non-COVID19 ICU arm (COVID-19 sub-study)

Description:

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.

Treatment:

Other: No intervention