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

Recruiting

• Conditions: Pain; Pediatric ALL

• Registration Number: NCT04913038
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-04
• Study Start: 2021-06-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Non sinusal rythm
• Atropine
• Pace-macker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesia Nociception Index (ANI) minimum	at 10 minutes before the painful care
ANI minimum	at 10 minutes after the painful care

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France