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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05454202
Acronym
ANI-CARE
Enrollment
20
Registered
2022-07-12
Start date
2022-09-22
Completion date
2024-05-24
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, End of Life, Pain

Keywords

Analgesia/Nociception Index, end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating, comfort evaluation, comfort monitoring, palliative care, non-communicating

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.

Interventions

DEVICEANI

Pain measurement during care procedures in palliative care

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variation of the ANI between before the care and during the careFrom 10 minutes before the care to 10 minutes after the care

Secondary

MeasureTime frame
Variation of the ANI between during the care and after the careFrom 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 periodsFrom 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 sessionFrom 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 scaleFrom 10 minutes before the care to 10 minutes after the care

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026