Clinical trial NCT05454202: Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Official title: Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End of Life
Pain
Analgesia
Keywords: Analgesia/Nociception Index
end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating
comfort evaluation
comfort monitoring
palliative care
non-communicating
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-communicating end-of-life patient hospitalized in palliative care

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of the ANI between before the care and during the care
timeFrame: From 10 minutes before the care to 10 minutes after the care
Secondary outcomes:
measure: Variation of the ANI between during the care and after the care
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: Coefficient of correlation between the variation of the ANI and the variation of the CPOT scale between each periods.
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: Coefficient of correlation between the minANI and the CPOT scale for each periods
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: Coefficient of correlations between ANImin and CPOT values before, during, and after the painful care session
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: The discriminatory power of the ANI to separate the non-comfortable and the comfortable population defined by a ≤ 2 threshold on the CPOT scale
timeFrame: From 10 minutes before the care to 10 minutes after the care
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Cardiologique Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Chloe PRODHOMME, MD
role: PRINCIPAL_INVESTIGATOR
References: