Precision Sedation in Intensive Care

NCT06991777 | Recruiting DMC FDA Device

• 1 other identifier: 24-04923
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Being critically ill and in need of mechanical ventilation is painful and distressing, and patients rarely have the capacity to communicate to express their needs. Doctors and nurses caring for critically ill patients in need of mechanical ventilation are constantly trying to balance patient comfort vs. patient safety. On one hand health care personnel (HCP) want to avoid unnecessary pain and suffering, on the other hand HCP want our patients to be able to communicate and avoid the complications associated with prolonged mechanical ventilation and Intensive Care Unit (ICU) stays. Our current tools for titrating sedation are subjective and variable, leading to large variations in sedation strategy between providers and frequent oversedation to "err on the side of caution". This project is a grassroot initiative where physicians and nurses across various ICUs at Oslo University Hospital are highly motivated to research an alternative strategy for sedation in our units. The investigators believe a more precise approach to sedation that uses neurophysiologic and respiratory targets to guide medication dosing will significantly improve our overall quality of care. By avoiding oversedation, the investigators hope to help our patients wean off mechanical ventilation quicker, reduce their risk of delirium and cognitive deficit, resulting in fewer complications and shorter ICU stays. More precise sedation not only has the potential to improve outcomes for individual patients, but it can also improve ICU capacity and reduce the costs associated with prolonged ICU stays.

Conditions

Critical Illness

Keywords

sedation; critical care; EEG; neurophysiology; respiratory

Outcome Measures

Primary Outcomes (1)

• Completeness of data in CRF

  Evaluate feasibility of recording all available processed EEG parameters (Bispectral index, suppression ratio, accumulated suppression time, spectral edge frequency and median frequency) and report as percentage of missing values. This information is to be used to adjust and improve data capture strategy prior to main trial.

  through study completion, an average of 7 days

Secondary Outcomes (6)

• Reported Adverse events (Safety)

  through study completion, an average of 7 days

• Length of intensive care stay

  through study completion, an average of 7 days

• Time to spontaneous eye opening

  through study completion, an average of 7 days

• Time to following commands

  through study completion, an average of 7 days

• Incidence of delirium

  through study completion, an average of 7 days

Study Arms (2)

Precision sedation in intensive care using neurophysiologic and respiratory targets.

EXPERIMENTAL

Precision sedation in intensive care using neurophysiologic and respiratory targets.

Device: Precision sedation in intensive care using neurophysiologic and respiratory targets.

Control

NO INTERVENTION

Sedation titration using standardized assessments (Richmond Agitation-Sedation Scale (RASS))

Interventions

Precision sedation in intensive care using neurophysiologic and respiratory targets. DEVICE

Sedation titration using EEG and ventilator parameters

Precision sedation in intensive care using neurophysiologic and respiratory targets.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to ICU
• Estimated need for sedation \> 24 hours

You may not qualify if:

• Patients admitted for palliative care
• Patients admitted with restrictions in care (no ventilator treatment)
• Contraindication for daily interruption of sedation

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0207, Norway

RECRUITING

Related Publications (20)

• Zhao D, Xu Y, He W, Li T, He Y. [A comparison of bispectral index and sedation agitation scale in guiding sedation therapy: a randomized controlled study in patients undergoing short term mechanical ventilation]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2011 Apr;23(4):220-3. Chinese.

  PMID: 21473824 BACKGROUND

• Weatherburn C, Endacott R, Tynan P, Bailey M. The impact of bispectral index monitoring on sedation administration in mechanically ventilated patients. Anaesth Intensive Care. 2007 Apr;35(2):204-8. doi: 10.1177/0310057X0703500208.

  PMID: 17444309 BACKGROUND

• Rasulo FA, Hopkins P, Lobo FA, Pandin P, Matta B, Carozzi C, Romagnoli S, Absalom A, Badenes R, Bleck T, Caricato A, Claassen J, Denault A, Honorato C, Motta S, Meyfroidt G, Radtke FM, Ricci Z, Robba C, Taccone FS, Vespa P, Nardiello I, Lamperti M. Processed Electroencephalogram-Based Monitoring to Guide Sedation in Critically Ill Adult Patients: Recommendations from an International Expert Panel-Based Consensus. Neurocrit Care. 2023 Apr;38(2):296-311. doi: 10.1007/s12028-022-01565-5. Epub 2022 Jul 27.

  PMID: 35896766 BACKGROUND

• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.

  PMID: 24937564 BACKGROUND

• Carrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. doi: 10.1186/cc697. Epub 2000 Jul 13.

  PMID: 11094504 BACKGROUND

• Akoumianaki E, Lyazidi A, Rey N, Matamis D, Perez-Martinez N, Giraud R, Mancebo J, Brochard L, Richard JM. Mechanical ventilation-induced reverse-triggered breaths: a frequently unrecognized form of neuromechanical coupling. Chest. 2013 Apr;143(4):927-938. doi: 10.1378/chest.12-1817.

  PMID: 23187649 BACKGROUND

• Dzierba AL, Khalil AM, Derry KL, Madahar P, Beitler JR. Discordance Between Respiratory Drive and Sedation Depth in Critically Ill Patients Receiving Mechanical Ventilation. Crit Care Med. 2021 Dec 1;49(12):2090-2101. doi: 10.1097/CCM.0000000000005113.

  PMID: 34115638 BACKGROUND

• 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.

  PMID: 33170331 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

• Quigley F, Rosenberg JM, Shachar-Hill Y, Bohnert HJ. From genome to function: the Arabidopsis aquaporins. Genome Biol. 2002;3(1):RESEARCH0001. doi: 10.1186/gb-2001-3-1-research0001. Epub 2001 Dec 7.

  PMID: 11806824 BACKGROUND

• Soliman HM, Melot C, Vincent JL. Sedative and analgesic practice in the intensive care unit: the results of a European survey. Br J Anaesth. 2001 Aug;87(2):186-92. doi: 10.1093/bja/87.2.186.

  PMID: 11493487 BACKGROUND

• Martin J, Franck M, Sigel S, Weiss M, Spies C. Changes in sedation management in German intensive care units between 2002 and 2006: a national follow-up survey. Crit Care. 2007;11(6):R124. doi: 10.1186/cc6189.

  PMID: 18062820 BACKGROUND

• Reschreiter H, Maiden M, Kapila A. Sedation practice in the intensive care unit: a UK national survey. Crit Care. 2008;12(6):R152. doi: 10.1186/cc7141. Epub 2008 Dec 1.

  PMID: 19046459 BACKGROUND

• Sessler CN, Varney K. Patient-focused sedation and analgesia in the ICU. Chest. 2008 Feb;133(2):552-65. doi: 10.1378/chest.07-2026.

  PMID: 18252923 BACKGROUND

• Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.

  PMID: 11902253 BACKGROUND

• Jackson DL, Proudfoot CW, Cann KF, Walsh T. A systematic review of the impact of sedation practice in the ICU on resource use, costs and patient safety. Crit Care. 2010;14(2):R59. doi: 10.1186/cc8956. Epub 2010 Apr 9.

  PMID: 20380720 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

• Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.

  PMID: 9726743 BACKGROUND

• Metnitz PG, Metnitz B, Moreno RP, Bauer P, Del Sorbo L, Hoermann C, de Carvalho SA, Ranieri VM; SAPS 3 Investigators. Epidemiology of mechanical ventilation: analysis of the SAPS 3 database. Intensive Care Med. 2009 May;35(5):816-25. doi: 10.1007/s00134-009-1449-9. Epub 2009 Mar 14.

  PMID: 19288079 BACKGROUND

• Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  PMID: 11790214 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Theresa M Olasveengen, MD PhD

CONTACT

+4741419930; uxothe@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 28, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)