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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-21

Study Completion Date

2020-01-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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: ventilated children

ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation with ANI/NIPE

Group Type OTHER

ANI/NIPE

Intervention Type 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).

Interventions

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ANI/NIPE

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).

Intervention Type DEVICE

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