ANI-EP: Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04913038
Collaborator
(none)
50
1
11.1
4.5

Study Details

Study Description

Brief Summary

The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.

In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.

To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.
    Actual Study Start Date :
    Jun 29, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    case group

    children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care.

    Outcome Measures

    Primary Outcome Measures

    1. Analgesia Nociception Index (ANI) minimum [at 10 minutes before the painful care]

    2. ANI minimum [at 30 minutes (average lenght of painful care)]

    3. ANI minimum [at 10 minutes after the painful care]

    Secondary Outcome Measures

    1. Variation of ANI minimum between before and after a painful care [From 10 minutes before the care to 10 minutes after the care]

    2. the correlation between ANI minimum and the COMFORT B behavioral scale. [From 10 minutes before the care to 10 minutes after the care]

      The COMFORT BEHAVIOURAL (COMFORT-B) SCALE consists of six items: alertness, calmness, respiratory response, body movements, facial tension and muscle tone. Each item goes from 1 to 5, assessing the different intensities. The sum of the six ratings leads to a final score ranging from a minimum of 6 to a maximum of 30. A patient is considered to be under-sedated in case of COMFORT-B scores of 23 or higher, over-sedated in case of COMFORT-B scores of 10 or lower.

    3. the ability of ANI minimum to distingush painful from non painful patient [From 10 minutes before the care to 10 minutes after the care]

    4. Area under the ROC curve of ANI min calculated over all measurements [From 10 minutes before the care to 10 minutes after the care]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated
    Exclusion Criteria:
    • Non sinusal rythm

    • Atropine

    • Pace-macker

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hop Jeanne de Flandre Chu Lille Lille France 59037

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Morgan RECHER, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04913038
    Other Study ID Numbers:
    • 2020_92
    • 2021-A00487-34
    First Posted:
    Jun 4, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille

    Study Results

    No Results Posted as of Oct 11, 2021