Clinical trial NCT05027217: Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit
Official title: Sedation, ANalgesia and Delirium MANagement: a Study of Medical, Surgical, Trauma, and Neuro-intensive Care Patients and a COVID-19 Sub-study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Sedation Complication
Intensive Care Unit Delirium
Analgesia
Covid19
Keywords: Intensive Care Unit
Delirium
Sedation
Analgesia
COVID-19
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2021-08-30
Enrollment: 3421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to ICU and mechanically ventilated for at least 12 hours.

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)

Eligibility 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

Primary outcomes:
measure: Sedation practice
timeFrame: First 7 days of mechanical ventilation
measure: Use of Pain, Analgesia and Delirium assessments
timeFrame: First 7 days of mechanical ventilation
Secondary outcomes:
measure: Adherence to PADIS guidelines
timeFrame: First 7 days of mechanical ventilation
measure: Sedation practice in different cohorts
timeFrame: First 7 days of mechanical ventilation
measure: Delirium
timeFrame: First 7 days of mechanical ventilation
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Sinai Health, Toronto (Canada)
name: Sangeeta Mehta, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.