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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05454202
Other study ID # 2021_0830
Secondary ID 2022-A00631-42
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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