Critical IllnessSAnDMANNCT05027217
Sedation, ANalgesia and Delirium MANagement in Intensive Care Unit
An observational study of Critical Illness and Sedation Complication, run by University of Oxford at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sedation Complication, Intensive Care Unit Delirium
- How many people
- 3,421 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted to ICU and mechanically ventilated for at least 12 hours.
Who may be able to join
- 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.
Show all 16Show fewer
- COVID-19 sub-study
- Data will be collected from patients who fulfil all the following inclusion criteria:
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
Study design: Multicentre Retrospective Observational Cohort Study with two-arm COVID-19 sub-study (same design)
- Being tested
- No intervention
- Keywords
- Intensive Care Unit, Delirium, Sedation, Analgesia, COVID-19
- Medical subject headings
- Critical Illness, Agnosia, COVID-19, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First 7 days of mechanical ventilation
Secondary outcomes (3)
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/
Measured: First 7 days of mechanical ventilation
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.
Measured: First 7 days of mechanical ventilation
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.
Measured: First 7 days of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Jan 2022
- Primary completion15 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Sangeeta Mehta, Prof, Principal investigator, Sinai Health, Toronto (Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027217
- Sponsor's protocol ID
- PID15072
- Other IDs
- Trials Group Award 2018
- Acronym
- SAnDMAN
- Status last verified
- May 2023
- First submitted
- 13 Aug 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30113379Chanques 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.
PubMed 33170331Tanios 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.
PubMed 31228760
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation, ANalgesia and Delirium MANagement: a Study of Medical, Surgical, Trauma, and Neuro-intensive Care Patients and a COVID-19 Sub-study.
- ClinicalTrials.gov ID
- NCT05027217
- Acronym / sponsor ID
- SAnDMAN / PID15072
- Keywords
- Intensive Care Unit, Delirium, Sedation, Analgesia, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,421 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ICU Arm (Main study) | – | Other: No interventionWe 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) | – | Other: No interventionWe 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. |
| Non-COVID19 ICU arm (COVID-19 sub-study) | – | Other: No interventionWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to ICU and mechanically ventilated for at least 12 hours.
Key inclusion criteria (16 listed)
- Main study
- 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
Key exclusion criteria (11 listed)
- Main study
- Patients admitted to non-acute care units
- COVID-19 sub-study
- COVID-19 ICU arm:
- Non-COVID-19 ICU arm:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU. | Other | COVID19 ICU arm (COVID-19 sub-study), Non-COVID19 ICU arm (COVID-19 sub-study), Standard ICU Arm (Main study) |
Primary outcome
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.
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.
3 secondary outcomes
Adherence to PADIS guidelines
Time frame: First 7 days of mechanical ventilation
Sedation practice in different cohorts
Time frame: First 7 days of mechanical ventilation
Delirium
Time frame: First 7 days of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Background: PubMed 30113379Devlin 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.
- Background: PubMed 33170331Chanques 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.
- Background: PubMed 31228760Tanios 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.
- ESICM Trials Group - Study documentsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Mehta, Prof principal investigator
Sinai Health, Toronto (Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sedation Complication, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation practice (time frame: First 7 days of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027217, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.