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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Analgesia; End of Life
• Intervention / Treatment: Device: ANI

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hop Cardiologique Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Non-communicating end-of-life patient hospitalized in palliative care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-communicating; Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old)	Device: ANI; Pain measurement during care procedures in palliative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Chloe PRODHOMME, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: palliative care; Analgesia/Nociception Index; end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating; comfort evaluation; comfort monitoring; non-communicating
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Death; Agnosia
• Other Study ID Numbers: 2021_0830; 2022-A00631-42 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No