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Clinical Trials/NCT04913038
NCT04913038CompletedNot Applicable

Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.

University Hospital, Lille1 site in 1 country50 target enrollmentStarted: June 29, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Analgesia Nociception Index (ANI) minimum
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated

Exclusion Criteria

  • •Non sinusal rythm
  • •Pace-macker

Outcomes

Primary Outcomes

Analgesia Nociception Index (ANI) minimum

Time Frame: at 10 minutes before the painful care

ANI minimum

Time Frame: at 10 minutes after the painful care

Secondary Outcomes

  • the correlation between ANI minimum and the COMFORT B behavioral scale.(From 10 minutes before the care to 10 minutes after the care)
  • the ability of ANI minimum to distingush painful from non painful patient(From 10 minutes before the care to 10 minutes after the care)
  • Variation of ANI minimum between before and after a painful care(From 10 minutes before the care to 10 minutes after the care)
  • Area under the ROC curve of ANI min calculated over all measurements(From 10 minutes before the care to 10 minutes after the care)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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