Neurophysiological Assessments During Continuous Sedation Until Death Put Validity of Observational Assessments Into Question: A Prospective Observational Study

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

Abstract

Introduction: In case of untreatable suffering at the end of life, continuous sedation until death (CSD) may be the only treatment option left. Because these patients cannot communicate anymore, caregivers have to rely on behavioral observation to assess the patient's comfort. Recently, however, a number of studies from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study was to find out if subjective caregiver assessments of consciousness and pain would be confirmed by objective neurophysiological measures.

Methods: In this prospective observational study, we observed patients from the start of palliative sedation until death. Subjective caregiver assessments of level of consciousness and pain based on behavioral observations were compared with objective measures from neurophysiological monitoring devices.

Results: We collected and analyzed 108 subjective caregiver assessments in a sample of 12 patients and 32 assessments by traditionally used observational scales. We compared these with objective neurophysiological measures. Sensitivity and specificity of caregivers' subjective assessments of consciousness was 23.6 and 91.1% respectively, with an accuracy of 54.0% and interrater reliability (κ) of 0.13. For pain, this was 0 and 94.79%, respectively, an accuracy of 88%, and an inter-rater reliability (κ) of - 0.063. Agreement between caregivers' subjective assessments and objective neurophysiological measures of consciousness and pain was very poor.

Conclusions: Caregivers' subjective assessment of level of consciousness and pain during CSD is unreliable compared with objective neurophysiological monitoring. Our results suggest that assessments of patient comfort during CSD could have been improved substantially by including objective monitoring of level of consciousness and pain.

Trial registration: The protocol for this observational study has been registered retrospectively at Clinical-Trials.gov (ID NCT03273244).

Keywords: Continuous sedation until death; Pain assessment; Palliative medicine; Unconsciousness.

Figures

Fig. 1
Fig. 1
a Scatterplot of WAVcns by NRSc. WAVcns wavelet anesthetic value for the central nervous system, NRSc numeric rating scale for consciousness, FN false negatives, TP true positives, TN true negatives, FP false positives. b Scatterplot of ANI by NRSp. ANI analgesia nociception index, NRSp numeric rating scale for pain, FN false negatives, TP true positives, TN true negatives, FP false positives

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