Assessment of Procedural Distress in Sedated/Intubated Children Under 3 Years Old Using the Newborn Infant Parasympathetic Evaluation: A Diagnostic Accuracy Pilot Study*

Abstract

Objectives: Newborn infant parasympathetic evaluation index is based on heart rate variability and is related to the autonomic response to pain or stress. The Comfort Behavior Scale is used to assess distress intensity in sedated intubated children. The objective of this study was to assess the validity and performance of newborn infant parasympathetic evaluation as a distress indicator during procedural distress. Design: Monocentric, prospective, noninterventional pilot study of diagnostic accuracy between October 1, 2017, and April 30, 2019. Setting: PICU in a tertiary care university hospital. Patients: Sedated intubated children under 3 years old. Interventions: We continuously obtained mean newborn infant parasympathetic evaluation and instantaneous newborn infant parasympathetic evaluation scores and compared them to Comfort Behavior scores obtained before (T1 period), during (T2 period), and after (T3 period) care procedures. Measurements and Main Results: We obtained 54 measurements from 32 patients. The median age was 4 months (23 d to 31 mo). Between T1 and T2, there was a significant decrease in the instantaneous newborn infant parasympathetic evaluation and mean newborn infant parasympathetic evaluation scores (64 ± 2 to 42 ± 1 [p < 0.0001] and 64 ± 1 to 59 ± 1 [p = 0.007], respectively) and a significant increase in the Comfort Behavior scores (from 12 ± 0 to 16 ± 1; p < 0.0001). Comfort Behavior scores and instantaneous newborn infant parasympathetic evaluation and mean newborn infant parasympathetic evaluation scores were significantly inversely correlated (r = –0.44, p < 0.0001 and r = –0.19, p = 0.01, respectively). With a instantaneous newborn infant parasympathetic evaluation score threshold of 53, the sensitivity, specificity, positive predictive, and negative predictive values to predict a Comfort Behavior Scale up to 17 were 80.0%, 73.5%, 43.8%, and 93.5%, respectively. Conclusions: Instantaneous newborn infant parasympathetic evaluation is valid for assessing distress in sedated/intubated children in the PICU. Further studies are needed to confirm these results and for newborn infant parasympathetic evaluation-based comparisons of sedation-analgesia protocols.

Comparison of the Newborn Infant Parasympathetic Evaluation (NIPE™) index to changes in heart rate to detect intraoperative nociceptive stimuli in healthy and critically ill children below 2 years: An observational study

“…Other recent studies also used the NIPE index to adequately evaluate the balance between nociception and antinociception, assess parasympathetic activity, pain and pleasant stimuli, and validly record stress and pain in sedated children. 10,18,19 It must be noted that, however, considerable interindividual variations in NIPE, reflected by not-so small standard deviations in our study, may be an explanation for some inconsistencies among the results of different studies, particularly at small group sizes. NIPE response may furthermore depend on the strength of the nociceptive stimulus, since venous puncture (which elicited no significant change in NIPE values in our study) is obviously a weaker stimulus than laryngoscopy/intubation and skin incision (and may be further weakened by additional local anesthesia of the skin that children usually receive to facilitate puncture).…”

“…Similar to our results, Zhang et al 12 showed a significant decrease in the NIPE index following intubation and initial skin incision in anesthetized infants. Other recent studies also used the NIPE index to adequately evaluate the balance between nociception and antinociception, assess parasympathetic activity, pain and pleasant stimuli, and validly record stress and pain in sedated children 10,18,19 . It must be noted that, however, considerable inter‐individual variations in NIPE, reflected by not‐so small standard deviations in our study, may be an explanation for some inconsistencies among the results of different studies, particularly at small group sizes.…”

Newborn infant parasympathetic evaluation for the assessment of analgosedation adequacy in infants treated by mechanical ventilation – a multicenter pilot study

“…performed research on newborns, infants and children <3 years of age treated in the PICU, who were intubated and under analgosedation, in which they compared changes in the NIPE index and the COMFORT score during various care procedures. They concluded that NIPEi is valid for assessing distress in sedated/intubated children in the PICU [ 46 ].…”

Monitoring of analgesia level during general anesthesia in children

“…Several studies concluded that NIPE could assess pain or discomfort in neonatology, neonatal or pediatric ICU, in 0-3 years old children [10,[36][37][38][39][40]. Some reports, however, yielded negative results [41,42]: the ability of NIPE to assess pain remains debated in nonintubated neonates, extreme preterm patients, and during very brief nociceptive procedures [43 & ].…”