Assessment of the Interest of ANI in the Non-communicatin... | NCT05454202

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

NCT05454202

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 26, 2025Actual

Enrollment

20Actual

Phase

Not provided

Conditions

End of Life
Pain
Analgesia

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-A00631-42	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2022Actual

Primary Completion Date

May 24, 2024Actual

Completion Date

May 24, 2024Actual

First Submitted Date

Jul 7, 2022

First Submission Date that Met QC Criteria

Jul 7, 2022

First Posted Date

Jul 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-communicating		Non-communicating (Glasgow ≤ 10) end-of-life patient hospitalized in palliative care (age ≥ 18 years old)	Device: ANI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANI	Device	Pain measurement during care procedures in palliative care	Non-communicating

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chloe PRODHOMME, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hop Cardiologique Chu Lille		Lille			France

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D010146	Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided