Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

Completed

• Conditions: Critical Illness; Covid19; Intensive Care Unit Delirium; Sedation Complication; Analgesia
• Interventions: Other: No intervention

• Registration Number: NCT05027217
• Lead Sponsor: University of Oxford

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)

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2022-01-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-30
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3421

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-COVID19 ICU arm (COVID-19 sub-study)	No intervention	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.
Standard ICU Arm (Main study)	No intervention	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.
COVID19 ICU arm (COVID-19 sub-study)	No intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Oxford; 🇬🇧 Oxford, United Kingdom