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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2024-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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End of Life Pain Analgesia

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-communicating

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

ANI

Intervention Type DEVICE

Pain measurement during care procedures in palliative care

Interventions

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ANI

Pain measurement during care procedures in palliative care

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloe PRODHOMME, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Cardiologique Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2021_0830

Identifier Type: -

Identifier Source: org_study_id

2022-A00631-42

Identifier Type: OTHER

Identifier Source: secondary_id