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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| : ventilated children | Other | ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation with ANI/NIPE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANI/NIPE | Device | 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). |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PELLUAU Sonia, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
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) |