NIPE as an Indicator of Pain in Sedated/Ventilated Patient Under 3 Years-old Hospitalized in Intensive Care Unit

Study Overview
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Brief Summary
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The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric intensive care unit.

Detailed Description
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The assessment of pain in patient hospitalized in intensive care remains a challenge, especially for patients which are unable to communicate their pain intensity. Self-reported scales are widely used for children's pain assessment but cannot be used in sedated or non-communicable patients. The gold standard for pain evaluation in sedated-ventilated patient in pediatric intensive care unit is the Comfort Behaviour Scale (CBS). However, this method remains subjective, depending on training and ability to use this clinical tool by the examiner. The Newborn Infant Parasympathetic Evaluation (NIPE) is a non-invasive system based on the analysis variability in high frequency (> 0.15 Hz) which reflects the parasympathetic activity related to respiratory fluctuations of heart rate. With a numerical index ranging from 0 to 100, NIPE values, measured continuously, has been developed to evaluate the degree of pain intensity. In this study, the hypothese is the NIPE could be used as an indicator of pain in sedated/intubated children under 3 years-old hospitalized in Pediatric intensive care unit. This study did not change the procedure of care before or after and had no impact on care.

Official Title
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Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit

Conditions
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Ventilator Lung; Newborn

Intervention / Treatment
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* Device: NIPE (MDoloris®) and CBS values


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patient ≤ 3 year-old, mechanically ventilated Exclusion Criteria: Withdraw life-support, unstable condition preventing planned routine procedures of care, conditions precluding the use of NIPE (cardiac transplant, absence of sinus cardiac rhythm, apnea or respiratory rate ≤ 25 /min, pacemaker and use of atropine and/or isoprenaline and conditions of days of availability for NIPE)

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children under 3 years-old intubated/sedated in intensive care<br>NIPE and CBS ware measured for each included patient | Device: NIPE (MDoloris®) and CBS values<br>* During different procedures of care with the bed-side nurse, NIPE ware recorded. Monitoring started 15 minutes before care and continuously recorded until 10 minutes after the procedure. Pain assessment was evaluated by the CBS under 3 periods for each patient: 1- before any procedure (T1) representing the baseline, 2- during the procedure of care (T2), and 3- after the procedure (T3). Investigator who performed the CBS was blind to NIPE during the procedure recording. This study did not change the procedure of care before or after and had no impact on care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn Infant Parasympathetic Evaluation | Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old | Through the study completion (18 months) | 
| Comfort Behaviour Scale | Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old | Through the study completion (18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn Infant Parasympathetic Evaluation | Determination of pain detection threshold with Newborn Infant Parasympathetic Evaluation scale (0 to 100) using receiving operator characteristics (ROC) curve | Through the study completion (18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Pain, Heart rate variability, Intensive care unit, Analgesia