Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit

Covid19 Clinical Trial

— SAnDMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027217
• Other study ID #: PID15072
• Secondary ID: Trials Group Awa
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3421
• Est. completion date: May 30, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• COVID-19
• Covid19
• Critical Illness
• Delirium
• Intensive Care Unit Delirium
• Sedation Complication

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adherence to PADIS guidelines	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/	First 7 days of mechanical ventilation
Secondary	Sedation practice in different cohorts	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.	First 7 days of mechanical ventilation
Secondary	Delirium	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.	First 7 days of mechanical ventilation

External Links

•   ESICM Trials Group - Study documents