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

NCT02834481 | Terminated

• 1 other identifier: RC31/15/7852
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Pain Care; Pediatric and Neonatal Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Determination of pain detection threshold with ANI/NIPE scale using receiving operator characteristics receiving operator characteristics (ROC) curve.

  Through the study completion (24 months)

• Determination of pain detection threshold with COMFORT B scale using ROC curve.

  Through the study completion (24 months)

• Evolution of ANI/NIPE value during pain care

  Through the study completion (24 months)

• Evolution of ANI/NIPE value during comfort care

  Through the study completion (24 months)

Study Arms (1)

: ventilated children

OTHER

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

Device: ANI/NIPE

Interventions

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).

: ventilated children

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ventilated children admitted in PICU postoperative of cardiac surgery with extracorporeal circulation, consent of the parental control, children benefiting from social security system

You may not qualify if:

• Heart rhythm disorder, use of heart rhythm disorder treatments, use of active pacemaker, which make ANI/NIPE values impossible to interpret

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PELLUAU Sonia, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 15, 2016
• Study Start: November 21, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)