Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol

NCT07032987 | Not Yet Recruiting

• 1 other identifier: IRAS number: 332457
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given. A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications. However, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients. Aims:

• To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients.
• To develop a sedation protocol for ECMO patients with input from patients, their family, and staff. Design/methods: Study 1: The investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2. Study 2: The investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group. Patient and public involvement/engagement: The investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public. Impact/dissemination: The investigators will share findings through social media, patient charities, research papers and conferences.

Conditions

Intensive Care Medicine; Respiratory Distress Syndrome (RDS); Sedation and Analgesia; ExtraCorporeal Membrane Oxygenation (ECMO); Sedation for Mechanical Ventilation; Cardiogenic Shock; Opioid Analgesia; Analgesia

Keywords

extracorporeal membrane oxygenation; sedation; opioid; sedatives; analgosedation; mechanical ventilation; ECMO; ICU; Intensive Care Unit; Critical Care; sedation protocol; analgesia

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  Death whilst in ICU

  Through study completion, an average of 1 year

Other Outcomes (2)

• ICU length of stay

  Through study completion, an average of 1 year

• Delirium

  Through study completion, an average of 1 year

Study Arms (4)

ECMO patients

Mechanically ventilated adult ICU patients who received ECMO organ support

Other: Not an intervention study

Healthcare professionals

Doctors, nurses and pharmacists who look after ECMO patients

Other: Not an intervention study

Non-ECMO

Mechanically ventilated adult ICU patients who did not receive ECMO organ support

Other: Not an intervention study

ECMO survivors and family

ECMO survivors who have recovered and discharged from hospital. Family of ECMO survivors.

Other: Not an intervention study

Interventions

Not an intervention study OTHER

This is not an intervention study

ECMO patients; ECMO survivors and family; Healthcare professionals; Non-ECMO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage 1: mechanically ventilated adult ICU patients Stage 2: Healthcare professionals (doctors, nurses and pharmacists) with experience caring for ECMO patients. ECMO survivors who have recovered and discharged from hospital, and their family.

You may qualify if:

• Aged 18 years and older.
• Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and/or propofol).
• Receiving ECMO for moderate to severe respiratory failure (PaO2/FiO2 (P/F) ratio \<20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.

You may not qualify if:

• Anticipated length of ICU stay in recruiting centre for less than 24 hours.
• Withdrawal of life-sustaining treatment in the next 24 hours.
• Stage 2 (mixed methods study):
• Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).
• ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.
• Family members of ECMO survivors, whose relative is no longer hospitalised.
• ECMO survivors currently receiving treatment in hospital.
• ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).
• ECMO survivors who cannot communicate in English.
• Non-ECMO survivors and family members.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, London, SE1 7EH, United Kingdom

Location

Related Publications (18)

• Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30.

  PMID: 25466317 BACKGROUND

• Rose RL, Bucknall T. Staff perceptions on the use of a sedation protocol in the intensive care setting. Aust Crit Care. 2004 Nov;17(4):151-9. doi: 10.1016/s1036-7314(04)80020-1.

  PMID: 18038524 BACKGROUND

• Shehabi Y, Bellomo R, Kadiman S, Ti LK, Howe B, Reade MC, Khoo TM, Alias A, Wong YL, Mukhopadhyay A, McArthur C, Seppelt I, Webb SA, Green M, Bailey MJ; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Sedation Intensity in the First 48 Hours of Mechanical Ventilation and 180-Day Mortality: A Multinational Prospective Longitudinal Cohort Study. Crit Care Med. 2018 Jun;46(6):850-859. doi: 10.1097/CCM.0000000000003071.

  PMID: 29498938 BACKGROUND

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

  PMID: 10816184 BACKGROUND

• 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

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Remmington C, McKenzie C, Camporota L, Hanks F, Barker M, Sanderson B, Rose L. Analgosedation in extracorporeal membrane oxygenation: a retrospective UK cohort study. Br J Anaesth. 2023 Aug;131(2):e50-e52. doi: 10.1016/j.bja.2023.05.011. Epub 2023 Jun 19. No abstract available.

  PMID: 37344336 BACKGROUND

• Grap MJ, Munro CL, Wetzel PA, Best AM, Ketchum JM, Hamilton VA, Arief NY, Pickler R, Sessler CN. Sedation in adults receiving mechanical ventilation: physiological and comfort outcomes. Am J Crit Care. 2012 May;21(3):e53-63; quiz e64. doi: 10.4037/ajcc2012301.

  PMID: 22549581 BACKGROUND

• Balzer F, Weiss B, Kumpf O, Treskatsch S, Spies C, Wernecke KD, Krannich A, Kastrup M. Early deep sedation is associated with decreased in-hospital and two-year follow-up survival. Crit Care. 2015 Apr 28;19(1):197. doi: 10.1186/s13054-015-0929-2.

  PMID: 25928417 BACKGROUND

• Kamdar BB, Combs MP, Colantuoni E, King LM, Niessen T, Neufeld KJ, Collop NA, Needham DM. The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU. Crit Care. 2016 Aug 18;19:261. doi: 10.1186/s13054-016-1433-z.

  PMID: 27538536 BACKGROUND

• Dzierba AL, Abrams D, Brodie D. Medicating patients during extracorporeal membrane oxygenation: the evidence is building. Crit Care. 2017 Mar 21;21(1):66. doi: 10.1186/s13054-017-1644-y.

  PMID: 28320466 BACKGROUND

• Shekar K, Abdul-Aziz MH, Cheng V, Burrows F, Buscher H, Cho YJ, Corley A, Diehl A, Gilder E, Jakob SM, Kim HS, Levkovich BJ, Lim SY, McGuinness S, Parke R, Pellegrino V, Que YA, Reynolds C, Rudham S, Wallis SC, Welch SA, Zacharias D, Fraser JF, Roberts JA. Antimicrobial Exposures in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation. Am J Respir Crit Care Med. 2023 Mar 15;207(6):704-720. doi: 10.1164/rccm.202207-1393OC.

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• Shekar K, Fraser JF, Smith MT, Roberts JA. Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care. 2012 Dec;27(6):741.e9-18. doi: 10.1016/j.jcrc.2012.02.013. Epub 2012 Apr 18.

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• Marhong JD, DeBacker J, Viau-Lapointe J, Munshi L, Del Sorbo L, Burry L, Fan E, Mehta S. Sedation and Mobilization During Venovenous Extracorporeal Membrane Oxygenation for Acute Respiratory Failure: An International Survey. Crit Care Med. 2017 Nov;45(11):1893-1899. doi: 10.1097/CCM.0000000000002702.

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• deBacker J, Tamberg E, Munshi L, Burry L, Fan E, Mehta S. Sedation Practice in Extracorporeal Membrane Oxygenation-Treated Patients with Acute Respiratory Distress Syndrome: A Retrospective Study. ASAIO J. 2018 Jul/Aug;64(4):544-551. doi: 10.1097/MAT.0000000000000658.

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MeSH Terms

Conditions

Respiratory Distress Syndrome; Agnosia; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Shock

Study Officials

• Louise Rose, PhD

  King's College London

  STUDY CHAIR

Central Study Contacts

Christopher Remmington, MPharm

CONTACT

+442078365454; christopher.remmington@nhs.net

Louise Rose, PhD

CONTACT

+4478365454; louise.rose@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 24, 2025
• Study Start: June 30, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available following publication of research findings in peer-reviewed manuscripts and presentation at international conferences.
• Access Criteria: Institution access will be needed to access any data. This includes permission to access the specific university and hospital servers. Potential users will require tools including Microsoft Excel and Microsoft Word to access and use the data, which are widely adopted in many institutions and sustainable. The data will be shared via the University repository KORDS but it will not be openly accessible. Requests for access to the data will be handled directly by the research team in line with local policies.

Locations

GB (1)