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

Completed

• Conditions: Ventilator Lung; Newborn
• Interventions: Device: NIPE (MDoloris®) and CBS values

• Registration Number: NCT04195672
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2019-04-25
• Study Completion: 2019-04-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children under 3 years-old intubated/sedated in intensive care	NIPE (MDoloris®) and CBS values	NIPE and CBS ware measured for each included patient

Primary Outcome Measures

Name	Time	Method
Newborn Infant Parasympathetic Evaluation	Through the study completion (18 months)	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
Comfort Behaviour Scale	Through the study completion (18 months)	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

Secondary Outcome Measures

Name	Time	Method
Newborn Infant Parasympathetic Evaluation	Through the study completion (18 months)	Determination of pain detection threshold with Newborn Infant Parasympathetic Evaluation scale (0 to 100) using receiving operator characteristics (ROC) curve

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHU; 🇫🇷 Lille, France