Assessment of Pain Monitoring With ANI/NIPE Monitor Program in Pediatric Cardiac Surgery Postoperative.

Study Overview
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Brief Summary
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The main objective is to assess correlation between ANI/NIPE values and external evaluation COMFORT B scale during painful medical cares and during said comfort medical cares in intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery with extracorporeal circulation.

Detailed Description
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ANI/NIPE monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. It uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia). Developed in surgical units, the ANI monitor has rarely been studied in pediatrics (only 2 publications, and only concerning peroperative measures). The NIPE monitor has only been available since 2014. Nevertheless, adult surveys and fundamental scientific publications on heart rate variations suggest that these monitors can evaluate pain on a continuous way. No study has been led in pediatric intensive care units. In our study, a continuous blinded monitoring will be set up as soon as patients' admittance for all eligible subjects. We will study, for children in cardiac post-surgery, ANI/ NIPE values and COMFORT B values during both painful and non-painful cares to determine correlation between those values. We will analyze a posteriori the ANI/NIPE values, through a standardized protocol, to recount the sequence of care and to determine discrepancies in drug consumption. Data gathering will be made in the first 48h after admittance in Pediatric Intensive Care Units (PICU). Patients will not be followed after leaving PICU.

Official Title
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ANI/NIPE Assessment of Pain Monitoring With ANI (Analgesia Nociceptive Index)/NIPE (Newborn Infant Parasympathetic Evaluation) Monitor Program in Pediatric Cardiac Surgery Postoperative.

Conditions
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Pain

Intervention / Treatment
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* Device: ANI/NIPE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation, consent of the parental control, children benefiting from social security system Exclusion Criteria: Heart rhythm disorder, use of heart rhythm disorder treatments, use of active pacemaker, which make ANI/NIPE values impossible to interpret

Ages Eligible for Study
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Maximum Age: 11 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: : ventilated children<br>ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation with ANI/NIPE | Device: ANI/NIPE<br>* ANI/NIPE monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. It uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between ANI/NIPE values and COMFORT B scale values assessed by coefficient of correlation in patients upper than two years old and in patients under two years old | coefficient correlation is used with confident interval of 95 per cent | Through the study completion (24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pain detection threshold with ANI/NIPE scale using receiving operator characteristics receiving operator characteristics (ROC) curve. | In comparison with COMFORT B scale | Through the study completion (24 months) | 
| Determination of pain detection threshold with COMFORT B scale using ROC curve. | In comparison with ANI/NIPE scale | Through the study completion (24 months) | 
| Evolution of ANI/NIPE value during pain care | assessed by scale value | Through the study completion (24 months) | 
| Evolution of ANI/NIPE value during comfort care | assessed by scale value | Through the study completion (24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Care, Pediatric and Neonatal Intensive Care Units