End of LifeANI-CARENCT05454202
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
An observational study of End of Life and Pain, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life, Pain, Analgesia
- What is being tested?
- ANI
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2022to 24 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-communicating end-of-life patient hospitalized in palliative care
Who may be able to join
- Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)
Who cannot join
- Non sinusal heart rate
- Respiratory rate < 9/min
- Treated by inotropes
- Pace-maker
- Patient in agonal phase
- Opposition from the guardian
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ANI
- Keywords
- Analgesia/Nociception Index, end-of-life, comfort evaluation, comfort monitoring, palliative care, non-communicating, comfort evaluation, comfort monitoring, palliative care, non-communicating
- Medical subject headings
- Death, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANIDevice
Pain measurement during care procedures in palliative care
| Study group | Role | What they receive |
|---|---|---|
| Non-communicating | Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old) Receives: Device: ANI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the ANI between before the care and during the care
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From 10 minutes before the care to 10 minutes after the care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start22 Sep 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloe PRODHOMME, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454202
- Sponsor's protocol ID
- 2021_0830
- Other IDs
- 2022-A00631-42
- Acronym
- ANI-CARE
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
- ClinicalTrials.gov ID
- NCT05454202
- Acronym / sponsor ID
- ANI-CARE / 2021_0830
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-communicating | – | Device: ANINon-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-communicating end-of-life patient hospitalized in palliative care
Key inclusion criteria (1 listed)
- Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)
Key exclusion criteria (6 listed)
- Non sinusal heart rate
- Respiratory rate < 9/min
- Treated by inotropes
- Pace-maker
- Patient in agonal phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANIPain measurement during care procedures in palliative care | Device | Non-communicating |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe PRODHOMME, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End of Life and Pain, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.