Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

Study Overview
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Brief Summary
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Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety. So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients. That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.

Official Title
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Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

Conditions
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End of Life, Pain, Analgesia

Intervention / Treatment
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* Device: ANI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10) Exclusion Criteria: Non sinusal heart rate Respiratory rate < 9/min Treated by inotropes Pace-maker Patient in agonal phase Opposition from the guardian

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-communicating<br>Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old) | Device: ANI<br>* Pain measurement during care procedures in palliative care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the ANI between before the care and during the care |  | From 10 minutes before the care to 10 minutes after the care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the ANI between during the care and after the care |  | From 10 minutes before the care to 10 minutes after the care | 
| Coefficient of correlation between the variation of the ANI and the variation of the CPOT scale between each periods. |  | From 10 minutes before the care to 10 minutes after the care | 
| Coefficient of correlation between the minANI and the CPOT scale for each periods |  | From 10 minutes before the care to 10 minutes after the care | 
| Coefficient of correlations between ANImin and CPOT values before, during, and after the painful care session |  | From 10 minutes before the care to 10 minutes after the care | 
| The discriminatory power of the ANI to separate the non-comfortable and the comfortable population defined by a ≤ 2 threshold on the CPOT scale |  | From 10 minutes before the care to 10 minutes after the care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia/Nociception Index, end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating, comfort evaluation, comfort monitoring, palliative care, non-communicating