Comfort in palliative sedation (Compas): a transdisciplinary mixed method study protocol for linking objective assessments to subjective experiences

Stefaan Six, Steven Laureys, Jan Poelaert, Johan Bilsen, Peter Theuns, Reginald Deschepper, Stefaan Six, Steven Laureys, Jan Poelaert, Johan Bilsen, Peter Theuns, Reginald Deschepper

Abstract

Background: In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain.

Methods: In this study we will observe 40 patients starting with initiation of palliative sedation until death. Assessment of comfort based on behavioral observations will be related with the results from a NeuroSense monitor, an EEG-based monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about comfort or discomfort condition, based on the parasympathetic tone. An innovative and challenging aspect of this study is its qualitative approach; "objective" and "subjective" data will be linked to achieve a holistic understanding of the study topic. The following data will be collected: assessment of pain/comfort by the patients themselves (if possible) by scoring a Visual Analogue Scale (VAS); brain function monitoring; monitoring of parasympathetic tone; caregivers' assessment (pain, awareness, communication); relatives' perception of the quality of the dying process; assessment by 2 trained investigators using observational scales; video and audio registration.

Discussion: Measuring pain and awareness in non-communicative dying patients is both technically and ethically challenging. ANI and EEG have shown to be promising technologies to detect pain that otherwise cannot be detected with the "traditional" methods. Although these technologies have the potential to provide objective quantifiable indicators for distress and awareness in non-communicative patients, strikingly they have not yet been used to check whether the current assessments for non-communicative patients are reliable.

Trial registration: The study is registered on ClinicalTrials.gov (Identifier: NCT03273244 ; registration date: 7.9.2017).

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study was obtained from the biomedical ethics committee of the University and University Hospital of Brussels (BUN 14320136504) and additional approval will be asked from each new recruitment site. All study information and patient consent forms are approved by the ethics committee. Written informed consent will be asked from the patient or his/her substitute decision maker.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Abarshi E, Rietjens J, Robijn L, Caraceni A, Payne S, Deliens L, et al. International variations in clinical practice guidelines for palliative sedation: a systematic review. BMJ Support Palliat Care. 2017;7:223–229.
    1. Laugsand EA, Kaasa S, de Conno F, Hanks G, Klepstad P. Research steering committee of the EAPC. Intensity and treatment of symptoms in 3,030 palliative care patients: a cross-sectional survey of the EAPC research network. J Opioid Manag. 2009;5:11–21. doi: 10.5055/jom.2009.0002.
    1. Puntillo KA, Arai S, Cohen NH, Gropper MA, Neuhaus J, Paul SM, et al. Symptoms experienced by intensive care unit patients at high risk of dying. Crit Care Med. 2010;38:2155–2160. doi: 10.1097/CCM.0b013e3181f267ee.
    1. Leemans K, Van den Block L, Bilsen J, Cohen J, Boffin N, Deliens L. Dying at home in Belgium: a descriptive GP interview study. BMC Fam Pract. 2012;13:4. doi: 10.1186/1471-2296-13-4.
    1. Ni Thuathail A. Welford C Pain assessment tools for older people with cognitive impairment Nurs Stand R Coll Nurs G B 1987. 2011;26:39–46.
    1. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), McGill pain questionnaire (MPQ), short-form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short Form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP) Arthritis Care Res. 2011;63:S240–S252. doi: 10.1002/acr.20543.
    1. Haugen DF, Hjermstad MJ, Hagen N, Caraceni A, Kaasa S. European palliative care research collaborative (EPCRC). Assessment and classification of cancer breakthrough pain: a systematic literature review. Pain. 2010;149:476–482. doi: 10.1016/j.pain.2010.02.035.
    1. Cade CH. Clinical tools for the assessment of pain in sedated critically ill adults. Nurs Crit Care. 2008;13:288–297. doi: 10.1111/j.1478-5153.2008.00294.x.
    1. Bilsen J, Cohen J, Chambaere K, Pousset G, Onwuteaka-Philipsen BD, Mortier F, et al. Medical end-of-life practices under the euthanasia law in Belgium. N Engl J Med. 2009;361:1119–1121. doi: 10.1056/NEJMc0904292.
    1. Schnakers C, Chatelle C, Majerus S, Gosseries O, De Val M, Laureys S. Assessment and detection of pain in noncommunicative severely brain-injured patients. Expert Rev Neurother. 2010;10:1725–1731. doi: 10.1586/ern.10.148.
    1. Kappesser J, Williams AC. de C. Pain estimation: asking the right questions. Pain. 2010;148:184–187. doi: 10.1016/j.pain.2009.10.007.
    1. Demertzi A, Schnakers C, Ledoux D, Chatelle C, Bruno M-A, Vanhaudenhuyse A, et al. Different beliefs about pain perception in the vegetative and minimally conscious states: a European survey of medical and paramedical professionals. Prog Brain Res. 2009;177:329–338. doi: 10.1016/S0079-6123(09)17722-1.
    1. Laureys S, Schiff ND. Coma and consciousness: paradigms (re)framed by neuroimaging. NeuroImage. 2012;61:478–491. doi: 10.1016/j.neuroimage.2011.12.041.
    1. Monti MM, Vanhaudenhuyse A, Coleman MR, Boly M, Pickard JD, Tshibanda L, et al. Willful modulation of brain activity in disorders of consciousness. N Engl J Med. 2010;362:579–589. doi: 10.1056/NEJMoa0905370.
    1. Laureys S, Pellas F, Van Eeckhout P, Ghorbel S, Schnakers C, Perrin F, et al. The locked-in syndrome : what is it like to be conscious but paralyzed and voiceless? Prog Brain Res. 2005;150:495–511. doi: 10.1016/S0079-6123(05)50034-7.
    1. Broeckaert Bert, Mullie Arsène, Gielen Joris, Desmet Marc, Declerck Dina, Vanden Berghe Paul, et al. Richtlijen palliatieve sedatie. [Guidelines for palliative sedation] [Internet]. Available from:
    1. Maltoni M, Scarpi E, Rosati M, Derni S, Fabbri L, Martini F, et al. Palliative sedation in end-of-life care and survival: a systematic review. J Clin Oncol Off J Am Soc Clin Oncol. 2012;30:1378–1383. doi: 10.1200/JCO.2011.37.3795.
    1. Raus K, Anquinet L, Rietjens J, Deliens L, Mortier F, Sterckx S. Factors that facilitate or constrain the use of continuous sedation at the end of life by physicians and nurses in Belgium: results from a focus group study. J Med Ethics. 2014;40(4):230. doi: 10.1136/medethics-2012-100571.
    1. Brown JE, Chatterjee N, Younger J, Mackey S. Towards a physiology-based measure of pain: patterns of human brain activity distinguish painful from non-painful thermal stimulation. PLoS One. 2011;6:e24124. doi: 10.1371/journal.pone.0024124.
    1. Sanders RD, Tononi G, Laureys S, Sleigh JW. Unresponsiveness ≠ unconsciousness. Anesthesiology. 2012;116:946–959. doi: 10.1097/ALN.0b013e318249d0a7.
    1. Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O’Neal PV, Keane KA, et al. The Richmond agitation-sedation scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002;166:1338–1344. doi: 10.1164/rccm.2107138.
    1. Claessens P, Menten J, Schotsmans P, Broeckaert B. Development and validation of a modified version of the Edmonton symptom assessment scale in a Flemish palliative care population. Am J Hosp Palliat Care. 2011;28:475–482. doi: 10.1177/1049909111400724.
    1. Chanques G, Payen J-F, Mercier G, de Lattre S, Viel E, Jung B, et al. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the behavioral pain scale. Intensive Care Med. 2009;35:2060–2067. doi: 10.1007/s00134-009-1590-5.
    1. Cruse D, Chennu S, Chatelle C, Bekinschtein TA, Fernández-Espejo D, Pickard JD, et al. Bedside detection of awareness in the vegetative state: a cohort study. Lancet Lond Engl. 2011;378:2088–2094. doi: 10.1016/S0140-6736(11)61224-5.
    1. Iannetti GD, Mouraux A. From the neuromatrix to the pain matrix (and back) Exp Brain Res. 2010;205:1–12. doi: 10.1007/s00221-010-2340-1.
    1. Barbato M. Bispectral index monitoring in unconscious palliative care patients. J Palliat Care. 2001;17:102–108.
    1. Barbato M, Barclay G, Potter J, Yeo W. Sedation and analgesia in unconscious palliative care patients: can Bispectral index monitoring add to our understanding? J Palliat Care. 2015;31:57–59. doi: 10.1177/082585971503100109.
    1. Chawla LS, Akst S, Junker C, Jacobs B, Seneff MG. Surges of electroencephalogram activity at the time of death: a case series. J Palliat Med. 2009;12:1095–1100. doi: 10.1089/jpm.2009.0159.
    1. Schulz E, Tiemann L, Schuster T, Gross J. Ploner M Neurophysiological coding of traits and states in the perception of pain Cereb Cortex N Y N 1991. 2011;21:2408–2414.
    1. De Couck M, Nijs J, Gidron Y. You may need a nerve to treat pain: the neurobiological rationale for vagal nerve activation in pain management. Clin J Pain. 2014;30:1099–1105. doi: 10.1097/AJP.0000000000000071.
    1. Giese-Davis J, Wilhelm FH, Tamagawa R, Palesh O, Neri E, Taylor CB, et al. Higher vagal activity as related to survival in patients with advanced breast cancer: an analysis of autonomic dysregulation. Psychosom Med. 2015;77:346–355. doi: 10.1097/PSY.0000000000000167.
    1. Masel EK, Huber P, Schur S, Kierner KA, Nemecek R, Watzke HH. Predicting discharge of palliative care inpatients by measuring their heart rate variability. Ann Palliat Med. 2014;3:244–249.
    1. Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Conf Proc Annu Int Conf IEEE Eng Med Biol Soc IEEE Eng Med Biol Soc Annu Conf. 2010;2010:1194–1197.
    1. Broucqsault-Dédrie C, De Jonckheere J, Jeanne M, Nseir S. Measurement of heart rate variability to assess pain in sedated critically ill patients: a prospective observational study. PLoS One. 2016;11:e0147720. doi: 10.1371/journal.pone.0147720.
    1. Masman AD, van Dijk M, van Rosmalen J. Blussé van Oud-Alblas HJ, Ista E, Baar FPM, et al. Bispectral index monitoring in terminally ill patients: a validation study. J Pain Symptom Manage 2016;52. 212–220:e3.
    1. Charmaz K. Constructing grounded theory. 2014.
    1. Deschepper R, Six S, Vandeweghe N, Couck MD, Gidron Y, Depoorter A-M, et al. Linking numbers to perceptions and experiences: Why we need transdisciplinary mixed-methods combining neurophysiological and qualitative data. Methodol Innov [Internet]. 2017 [cited 2017 Dec 22]; Available from:
    1. Measuring Comfort During Palliative Sedation - Full Text View - [Internet]. [cited 2017 Sep 26]. Available from:

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner