Skip to main content
OpenTrials
Completed

NCT Number: NCT05454202

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End of Life Agnosia Analgesia Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Cardiologique Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANI

Device

Pain measurement during care procedures in palliative care

Primary outcomes

  1. Variation of the ANI between before the care and during the care

    Time frame: From 10 minutes before the care to 10 minutes after the care

Secondary outcomes

  1. Variation of the ANI between during the care and after the care

    Time frame: From 10 minutes before the care to 10 minutes after the care

  2. Coefficient of correlation between the variation of the ANI and the variation of the CPOT scale between each periods.

    Time frame: From 10 minutes before the care to 10 minutes after the care

  3. Coefficient of correlation between the minANI and the CPOT scale for each periods

    Time frame: From 10 minutes before the care to 10 minutes after the care

  4. Coefficient of correlations between ANImin and CPOT values before, during, and after the painful care session

    Time frame: From 10 minutes before the care to 10 minutes after the care

  5. The discriminatory power of the ANI to separate the non-comfortable and the comfortable population defined by a ≤ 2 threshold on the CPOT scale

    Time frame: From 10 minutes before the care to 10 minutes after the care

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ANI-CARE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.