NCT04195672

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator Lung; Newborn

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-04-25
• Completion: 2019-04-30
• First posted: 2019-12-12
• Last updated: 2019-12-12

Locations

1 site across 1 country: France