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Completed

NCT Number: NCT05027217

Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

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.

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Key information

Conditions

Critical Illness Agnosia Analgesia COVID-19 Confusion Coronaviridae Infections Coronavirus Infections Covid19 Delirium Disease Attributes Infections Intensive Care Unit Delirium Lung Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sedation Complication Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, OX3 9DU, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Main study

Data will be collected from patients who fulfil all the following inclusion criteria:

  • 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:

  • 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

Treatment and study plan

No intervention

Other

No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.

Primary outcomes

  1. Sedation practice

    Time frame: 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.

  2. Use of Pain, Analgesia and Delirium assessments

    Time frame: 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 outcomes

  1. Adherence to PADIS guidelines

    Time frame: 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/

  2. Sedation practice in different cohorts

    Time frame: 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.

  3. Delirium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Acronym: SAnDMAN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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