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

Pain Clinical Trial

— ANI-CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454202
• Other study ID #: 2021_0830
• Secondary ID: 2022-A00631-42
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: September 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Lille
• Contact: Chloe PRODHOMME, MD
• Phone: 0320445962
• Email: chloe.prodhomme[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Death
• End of Life
• Pain

Intervention

Device:
• ANI
Pain measurement during care procedures in palliative care

Locations

Country	Name	City	State
France	Hop Cardiologique Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variation of the ANI between during the care and after the care		From 10 minutes before the care to 10 minutes after the care
Secondary	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
Secondary	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
Secondary	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
Secondary	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