Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator Lung; Newborn
- Sponsor
- University Hospital, Lille
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Newborn Infant Parasympathetic Evaluation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Newborn Infant Parasympathetic Evaluation
Time Frame: 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
Time Frame: 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 Outcomes
- Newborn Infant Parasympathetic Evaluation(Through the study completion (18 months))