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

Ventilator Lung; Newborn Clinical Trial

— NIPE  

Official title:

Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195672
• Other study ID #: NI2019_
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 30, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Ventilator Lung; Newborn

Intervention

Device:
• NIPE (MDoloris®) and CBS values
During different procedures of care with the bed-side nurse, NIPE ware recorded. Monitoring started 15 minutes before care and continuously recorded until 10 minutes after the procedure. Pain assessment was evaluated by the CBS under 3 periods for each patient: 1- before any procedure (T1) representing the baseline, 2- during the procedure of care (T2), and 3- after the procedure (T3). Investigator who performed the CBS was blind to NIPE during the procedure recording. This study did not change the procedure of care before or after and had no impact on care

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn Infant Parasympathetic Evaluation	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	Through the study completion (18 months)
Primary	Comfort Behaviour Scale	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	Through the study completion (18 months)
Secondary	Newborn Infant Parasympathetic Evaluation	Determination of pain detection threshold with Newborn Infant Parasympathetic Evaluation scale (0 to 100) using receiving operator characteristics (ROC) curve	Through the study completion (18 months)