Clinical trial NCT04195672: NIPE as an Indicator of Pain in Sedated/Ventilated Patient Under 3 Years-old Hospitalized in Intensive Care Unit
Official title: Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Lung; Newborn
Keywords: Pediatric
Pain
Heart rate variability
Intensive care unit
Analgesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 32
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patient ≤ 3 year-old, mechanically ventilated

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Newborn Infant Parasympathetic Evaluation
timeFrame: Through the study completion (18 months)
measure: Comfort Behaviour Scale
timeFrame: Through the study completion (18 months)
Secondary outcomes:
measure: Newborn Infant Parasympathetic Evaluation
timeFrame: Through the study completion (18 months)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: morgan Recher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Recher M, Rousseaux J, Flocteil M, Jouancastay M, Potisek A, Lampin ME, Leteurtre S, De Jonckheere J. Assessment of Procedural Distress in Sedated/Intubated Children Under 3 Years Old Using the Newborn Infant Parasympathetic Evaluation: A Diagnostic Accuracy Pilot Study. Pediatr Crit Care Med. 2020 Dec;21(12):e1052-e1060. doi: 10.1097/PCC.0000000000002454.