Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit (SAnDMAN)

June 5, 2023 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

3421

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.
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
No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.
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
No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 7 days of mechanical ventilation
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.
First 7 days of mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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/
First 7 days of mechanical ventilation
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.
First 7 days of mechanical ventilation
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.
First 7 days of mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Sangeeta Mehta, Prof, Sinai Health, Toronto (Canada)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID15072
  • Trials Group Award 2018 (Other Grant/Funding Number: European Society of Intensive Care Medicine (ESICM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

SANDMAN investigators will be given priority to lead secondary analyses and are encouraged to do so. Participation and authorship opportunities will be based on contribution to the primary study. The study steering committee will consider the scientific validity and the possible effect on the anonymity of participating centres prior to granting any such requests. Where necessary, a prior written agreement may be requested to set out the terms of such collaborations. Investigators should submit a secondary study proposal for review by the Executive committee. 'Cleaned' data from the international or national datasets will only be released after a secondary study proposal has been approved. An analysis involving any data derived from the SANDMAN study will be considered a secondary analysis and subject to these rules.

IPD Sharing Time Frame

After the main study report is published.

IPD Sharing Access Criteria

Upon request to the study Executive Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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