Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

NCT05027217 | Completed

• 2 other identifiers: PID15072Trials Group Award 2018
• Study Type: observational
• Target: 3,421
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intensive Care Unit; Delirium; Sedation; Analgesia; COVID-19

Outcome Measures

Primary Outcomes (2)

• Sedation practice

  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.

  First 7 days of mechanical ventilation

• Use of Pain, Analgesia and Delirium assessments

  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.

  First 7 days of mechanical ventilation

Secondary Outcomes (3)

• Adherence to PADIS guidelines

  First 7 days of mechanical ventilation

• Sedation practice in different cohorts

  First 7 days of mechanical ventilation

• Delirium

  First 7 days of mechanical ventilation

Study Arms (3)

Standard ICU Arm (Main study)

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.

Other: No intervention

COVID19 ICU arm (COVID-19 sub-study)

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.

Other: No intervention

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

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.

Other: No intervention

Interventions

No intervention OTHER

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

COVID19 ICU arm (COVID-19 sub-study); Non-COVID19 ICU arm (COVID-19 sub-study); Standard ICU Arm (Main study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Main study
• \. 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
• 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.

You may not qualify if:

• Main study
• \. Standard ICU arm:
• Patients admitted to non-acute care units
• COVID-19 sub-study
• 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

Sponsors & Collaborators

• University of Oxford: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

University of Oxford

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (3)

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 BACKGROUND

• Chanques G, Constantin JM, Devlin JW, Ely EW, Fraser GL, Gelinas C, Girard TD, Guerin C, Jabaudon M, Jaber S, Mehta S, Langer T, Murray MJ, Pandharipande P, Patel B, Payen JF, Puntillo K, Rochwerg B, Shehabi Y, Strom T, Olsen HT, Kress JP. Analgesia and sedation in patients with ARDS. Intensive Care Med. 2020 Dec;46(12):2342-2356. doi: 10.1007/s00134-020-06307-9. Epub 2020 Nov 10.

  PMID: 33170331 BACKGROUND

• Tanios M, Nguyen HM, Park H, Mehta S, Epstein SK, Youssef F, Beltran A, Flores G, Sidhom R, Sehgal A, Leo J, Devlin JW. Analgesia-first sedation in critically ill adults: A U.S. pilot, randomized controlled trial. J Crit Care. 2019 Oct;53:107-113. doi: 10.1016/j.jcrc.2019.06.008. Epub 2019 Jun 12.

  PMID: 31228760 BACKGROUND

Related Links

• ESICM Trials Group - Study documents

MeSH Terms

Conditions

Critical Illness; Agnosia; COVID-19; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sangeeta Mehta, Prof

  Sinai Health, Toronto (Canada)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 30, 2021
• Study Start: January 1, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 30, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the main study report is published.
• Access Criteria: Upon request to the study Executive Committee

Locations

GB (1)