Measuring Comfort During Palliative Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-12

Study Completion Date

2019-09-30

Brief Summary

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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 certainly 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 (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these traditional behavioral methods.

Therefore there is an urgent need for a more reliable way of assessment by combining existing observational scales, subjective assessments of caregivers and family and neuroimaging techniques.

Aim. 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 the investigators will observe 40 patients starting with initiation of palliative sedation until death.

Assessment of comfort based on behavioural observations will be related with the results from a NeuroSense monitor, an EEG-based brain 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 the comfort or discomfort condition of the organism, based on the parasympathetic tone (including calculation of ANI). Additionally, the researchers will investigate whether changes of these measures can be linked to changes in the patients' experience as observed by caregivers and relatives, especially in the last moments of life. An innovative and challenging aspect of this study is its qualitative approach, implying all the different types of data will be used to link "objective" and "subjective" data to achieve a holistic understanding of the study topics.

The following data will be collected:

* assessment of pain/comfort by the patients themselves before loss of consciousness due to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)
* brain function monitoring (NeuroSense monitor)
* monitoring of parasympathetic tone (ANI monitor)
* assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)
* relatives' perception of the quality of the dying process on 3 VAS scales (idem)
* assessment by 2 trained investigators using observational scales
* observation: video and audio registration

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Detailed Description

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Conditions

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Palliative Sedation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Device monitoring

NeuroSense monitoring and ANI monitoring

Intervention Type DEVICE

From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.

Interventions

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NeuroSense monitoring and ANI monitoring

From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients may be included if they are considered by their treating physician as:

1. in their last week of life
2. in conditions that might, when not treated, cause high levels of distress
3. sedated
4. unable to communicate