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

NCT05454202 | Completed

• 2 other identifiers: 2021_08302022-A00631-42
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Non-communicating

Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old)

Device: ANI

Interventions

ANI DEVICE

Pain measurement during care procedures in palliative care

Non-communicating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)

You may not qualify if:

• Non sinusal heart rate
• Respiratory rate \< 9/min
• Treated by inotropes
• Pace-maker
• Patient in agonal phase
• Opposition from the guardian

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Cardiologique Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Death; Pain; Agnosia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Chloe PRODHOMME, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: September 22, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)