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

NCT04195672 | Completed

• 1 other identifier: NI2019_
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Lung; Newborn

Keywords

Pediatric; Pain; Heart rate variability; Intensive care unit; Analgesia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Newborn Infant Parasympathetic Evaluation

  Through the study completion (18 months)

Study Arms (1)

Children under 3 years-old intubated/sedated in intensive care

NIPE and CBS ware measured for each included patient

Device: NIPE (MDoloris®) and CBS values

Interventions

NIPE (MDoloris®) and CBS values DEVICE

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

Children under 3 years-old intubated/sedated in intensive care

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patient ≤ 3 year-old, mechanically ventilated

You may qualify if:

• All consecutive patient ≤ 3 year-old, mechanically ventilated

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 32740184 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Pain; Agnosia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• morgan Recher, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 12, 2019
• Study Start: November 1, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 30, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

FR (1)