Resuscitation 85 (2014) 1568–1572

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Clinical Paper

Pedi-cap color change precedes a significant increase in heart rate during neonatal resuscitation夽 Doug Blank a,∗ , Wade Rich a , Tina Leone b , Donna Garey a , Neil Finer a a b

Division of Neonatology, UCSD Medical Center, University of California, San Diego, CA, USA Division of Neonatology, Columbia University, New York, NY, USA

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Article history: Received 21 March 2014 Received in revised form 19 August 2014 Accepted 21 August 2014 Keywords: End tidal carbon dioxide Pedi-Cap Heart rate Saturation of peripheral oxygen Electrocardiogram Positive pressure ventilation

a b s t r a c t Introduction: Heart rate is the most important indicator of infant well-being during neonatal resuscitation. The Nellcor Pedi-Cap turns gold when exposed to exhaled gas with CO2 > 15 mmHg. The aim of this study was to determine if Pedi-Cap gold color change during neonatal resuscitation precedes an increase in heart rate in babies with bradycardia receiving mask ventilation. Methods: This was a single-center retrospective review of video recordings and physiologic data of newborns with bradycardia receiving mask positive pressure ventilation during neonatal resuscitation. Subjects were included if the baby’s HR < 100 BPM within the first 90 s of resuscitation. The primary outcome was the change in HR prior to Pedi-Cap gold color change compared to the HR after Pedi-Cap gold color change. Results: Forty-one newborns during the study period had HR < 100 BPM and received mask positive pressure ventilation with a Pedi-Cap. The median heart rate 10 s prior to Pedi-Cap gold color change was 75 BPM (IQR 62–85) and increased to 136 BPM (IQR 113–158) 30 s after gold color change (p < 0.001). SpO2 increased from 45 ± 17% prior to Pedi-Cap gold color change to 52 ± 17% 30 s after gold color change (p = 0.001). Conclusions: Colorimetric CO2 detection during mask positive pressure ventilation in neonatal resuscitation precedes a significant increase in heart rate and SpO2 . The Pedi-Cap can be easily applied during resuscitation, requires no electricity, provides immediate feedback and may be a useful, simple tool early in resuscitation and may be especially useful in resource limited settings. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction Heart rate is the most important indicator of infant well-being during neonatal resuscitation. The American Academy of Pediatrics Neonatal Resuscitation Program guidelines recommends adequate ventilation as the key intervention during neonatal resuscitation to improve cardiac output and stimulate breathing. Inflating the neonatal lung establishes functional residual capacity, stimulates pulmonary blood flow and improves heart rate.1–3 The Pedi-Cap® (Nellcor Puritan Bennett, Pleasanton, CA) is an example of a semi-quantitative, single-use colorimetric carbon dioxide detector. The Pedi-Cap contains a pH-sensitive chemical indicator that undergoes cyclical color change with each

夽 A Spanish translated version of the summary of this article appears as Appendix in the final online version at http://dx.doi.org/10.1016/j.resuscitation.2014.08.027. ∗ Corresponding author at: Division of Neonatology, UCSD Medical Center, 402 Dickinson Street, MPF 1-140 #8774, USA. E-mail address: [email protected] (D. Blank). http://dx.doi.org/10.1016/j.resuscitation.2014.08.027 0300-9572/© 2014 Elsevier Ireland Ltd. All rights reserved.

inspiration and expiration when it is placed in an infant’s breathing circuit. During effective ventilation, the Pedi-Cap will “cycle” between purple and gold with each delivered breath. Disposable colorimetric CO2 detectors are recommended to confirm successful endotracheal tube placement during neonatal resuscitation and can also be used to qualify airway patency during mask positive pressure ventilation.1,2,4–8 At UCSD Medical Center all babies that are at risk for requiring extensive resuscitation at birth are evaluated in a designated resuscitation suite outfitted with high definition audio/video monitoring along with multi-channel analog data capture.9–11 In an ongoing quality improvement review of the recorded resuscitations, we observed that large increases in HR were associated with PediCap gold color change (PGC). CO2 detection may be the first signal that there is adequate lung inflation, pulmonary blood flow and gas exchange. Several studies have demonstrated that assessment of HR via auscultation and palpation is inaccurate during neonatal resuscitation.12–14 An additional method of determining an increase in HR during neonatal resuscitation may helpful, especially in resource limited settings where resuscitation is often performed

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by single providers without the availability of pulse oximetry.15–17 We hypothesized that PGC during mask ventilation would precede an increasing heart rate during neonatal resuscitation. 2. Methods This is a retrospective review of data obtained during neonatal resuscitations conducted at the UCSD Medical Center, a 49 bed regional neonatal intensive care unit with a high-risk perinatal service averaging 3500 deliveries per year. The team attending each delivery consisted at minimum of a neonatal fellow or neonatal nurse practitioner, a respiratory therapist and a neonatal nurse. 2.1. Inclusion criteria All available real-time physiologic data and high definition video and audio recordings between April 2012 and November 2012 were obtained using our previously described data acquisition system.9–11 Data was analyzed and included if the baby’s HR was 100 BPM and SpO2 increases >20%.

to detect airway obstruction during mask PPV. The data acquisition system recorded the pressure of each manual inflation delivered. The need to intubate was determined by the clinical team. If the baby did not require intubation as part of the resuscitation (i.e. did not need intubation for bradycardia, did not receive chest compressions or require epinephrine), our practice was to consider intubation in the delivery room if the baby required more than 0.4 FiO2 to maintain SpO2 in targeted ranges recommended by NRP or was still requiring mask PPV for treatment of apnea prior to transport to the NICU. All physiologic data captured from the monitors was converted to digital form using a data acquisition system (MP 150 [Biopac Systems, Inc., Goleta, CA]) and integrated with the digital video signal using previously described methods.9−11 The standard data captured includes pulse and saturation values from an oximeter, airway pressure, FiO2 and heart rate from ECG (Fig. 1). We recorded the HR and SpO2 for each baby every 30 s for the first 5 min of the resuscitation. To analyze the HR and SpO2 during PGC, we recorded the HR and SpO2 in 10 s intervals from 30 s prior to PGC to 30 s after PGC. Interventions performed by the team to stabilize the baby as well as patient demographic characteristics and clinical outcomes were recorded. Resuscitations were reviewed as part of an ongoing quality improvement project. Data for each delivery was obtained from our quality improvement database. The institutional review board of UCSD approved a waiver of consent for this study. 2.4. Statistics Comparisons of HR and SpO2 , at single time points, before and after PGC were analyzed using repeated measures analysis of variance (ANOVA) for normally distributed data and the Friedman test for non-parametric data. Post hoc analysis was conducted using a Bonferroni adjustment. A paired T-Test was used to compare normally distributed data and a Wilcoxon signed-rank test was used to compare non-parametric data. Means with SD are reported for normally distributed continuous variables and medians with 25–75% interquartile ranges are reported when the distribution was skewed. Demographic data are presented as numbers and proportions for categorical variables. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of PGC to indicate a HR > 100 BPM was measured every 30 s for the first 5 min of the resuscitation. We assigned a true positive if the Pedi-Cap was gold and the HR was >100 BPM and a true negative if the Pedi-Cap was purple and the HR < 100 BPM. To test inter-rater reliability of when Pedi-Cap gold color change occurs, three clinicians independently watched 15

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Table 1 Demographic data, N = 41. Gestational age at birth, weeks, median (IQR) Birth weight, grams mean (IQR) Infants < 1000 g, % Infants < 1500 g, % Infants < 34 weeks, % Male, % C-Section, % 100 BPM, PGC had an accuracy of 95% and the pulse oximeter had a reliable signal in 93% of babies. There were no mechanical failures of the Pedi-Cap observed in any infant included in this study. Sixty-one percent of the babies (25/41) received more than 10 min of mask PPV. Of the remaining 16 babies, the median duration of mask PPV was 278 s (135–313). Twenty-seven percent of the babies (11/41) were intubated in the delivery room. One baby was intubated prior to 5 min of resuscitation. Eighty percent (33/41) were intubated in the first week of life for respiratory failure, surfactant administration, or apnea. One baby received chest compressions. A Spearman’s rank-order test confirmed there was a strong positive correlation of the three independent clinicians reporting the time of PGC (rs (15) = 0.952, 0.962 and 0.982, p < 0.001).

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et al. showed that mortality from birth asphyxia in 8 hospitals in Tanzania was decreased by 47% after implementing the Helping Babies Breathe program.16 However, the reduced rate of death from birth asphyxia was still twice the rate early neonatal death from all causes in the US.24 Colorimetric CO2 detectors are portable, non-powered devices, that can be applied quickly to virtually any ventilation apparatus in an emergent situation. We believe that colorimetric CO2 detection during neonatal resuscitation has important implications to enhance the education and improve performance of providers in resource limited settings. Colorimetric CO2 detectors are visualized in the same field of view as the infant and provide feedback on technique of mask ventilation, airway obstruction, lung inflation and overall progress of the resuscitation. Therefore a single provider may be able to continue PPV without interruption of PPV to check a HR. The Pedi-Cap can be used at the beginning of the neonatal transition to determine if the infant is breathing and has pulmonary perfusion and therefore a HR. In some circumstances, PGC may indicate that an infant who appears non-viable has circulation and breathing. In our experience, even with sophisticated monitoring equipment, colorimetric CO2 detection is often the first sign that the infant is improving. We were able to compare the accuracy of the HR provided by the pulse oximeter with PGC because we used an ECG monitor which provided a reliable early HR. Early in the resuscitation, PGC may be a more reliable signal of HR. Early recognition of a rising heart rate may prevent the administration of unneeded additional oxygen or inflation pressures during resuscitation.

4. Discussion Previous studies demonstrated the utility of colorimetric CO2 detectors in confirming intubation and detecting airway obstruction.4–8,18,21 Using video recording and a data acquisition system which includes an ECG monitor to provide an early HR signal, we have demonstrated that colorimetric CO2 detection precedes an increasing HR and SpO2 in infants receiving mask PPV during neonatal resuscitation. Hooper et al. used phase contrast X-ray imaging on an animal model of intubated preterm rabbits at birth to investigate the relationship between end tidal CO2 and lung aeration. They demonstrated that increasing lung volumes were closely related to increasing end tidal CO2 detection and expired CO2 levels >10 mmHg preceded a rise in heart rate to >100 BPM in 10 preterm infants with bradycardia.22 Chalak, et al. investigated levels of end tidal CO2 that corresponded with return of spontaneous circulation in an animal model of hypoxia induced asystole in 46 intubated term newborn piglets. They reported that using an end tidal CO2 of 15 mmHg had 96% specificity for a HR greater than 60 obtained by auscultation.23 PGC corresponds to a level of CO2 > 15 mmHg. In this cohort, tan Pedi-Cap color change, representing exhaled CO2 between 0.5 and 2%, did not precede a rise in HR. There was a median of 14 s (6–33) between initiating PPV and tan color change and an additional 30 s (15–48) between tan color change and PGC. There was no difference in HR between tan color change and PGC, the median HR remained 78 BPM (67–89) during this period. In one baby, we noted PCG after the initiation of chest compressions. Consistent with our clinical experience, in every circumstance PGC change occurs after the initiation of chest compressions. Further investigation is needed to determine the threshold expired CO2 level that precedes an increase in HR. In resource limited settings, resuscitation of newborns is often performed by single providers without the availability of pulse oximetry. Helping Babies Breathe is a program supported by the American Academy of Pediatrics aimed at decreasing death from birth asphyxia in resource limited environments.15–17 Msemo

4.1. Limitations The limitations of this study include that it is a retrospective review. It is possible that the HR and SpO2 would have risen without intervention by the clinical team. Regardless, PGC preceded an increase in HR and SpO2 . The Pedi-Cap introduces a small amount of dead space (3 mL) and resistance (0.2 cmH2 O/L at 8 L/min of flow). Providers must be aware that there are several causes to failure of PGC including inadequate lung ventilation, upper airway obstruction, large mask leaks and inadequate pulmonary blood flow. Certain substances, including water and epinephrine, can cause the Pedi-Cap to turn permanently gold. During effective ventilation or spontaneous breathing, a properly functioning Pedi-Cap will cycle between purple and gold. Providers must be able to distinguish the color ranges of each device (eFigure). Colorimetric end tidal CO2 detectors are currently too expensive to be a practical addition to resuscitation equipment in resource limited environments without further validation. The threshold for PGC is 15 mmHg. This threshold may be appropriate to indicate a rising HR after lung inflation and adequate pulmonary blood flow, but may be inadequate to detect periods of ventilation during low pulmonary blood flow after lung inflation, as may occur with the first few breaths. Nicoll et al. continued to detect end tidal CO2 > 15 mmHg and PGC after cardiac arrest in newborn piglets, suggesting a CO2 washout period during low pulmonary blood flow.25 There were 3 babies without an increase in HR within 30 s of PGC. One baby had PGC after the initiation of chest compressions during mask PPV. The other two babies had 2 mask adjustments in the 30 s after PGC, with loss of PEEP. Once ventilation was reestablished, the HR increased quickly, within 60 s of PGC, without an increase in PIP or FiO2 . In conclusion, Pedi-Cap gold color change precedes an increase in HR and SpO2 during mask positive pressure ventilation in babies with bradycardia at birth. Clinical trials are needed to address the potential utility of the colorimetric CO2 detectors during neonatal resuscitation in resource limited settings.

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Conflict of interest statement The authors have no conflicts of interest. This study was conducted without an external source of funding. References 1. Kattwinkel J, editor. Textbook of neonatal resuscitation. 6th ed. Elk Grove Village, IL: American Academy of Pediatrics, American Heart Association; 2010. 2. Kattwinkel J, Perlman JM, Aziz K, et al. Neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Pediatrics 2010;126:e1400–13. 3. te Pas AB, Davis PG, Hooper SB, Morley CJ. From liquid to air: breathing after birth. J Pediatr 2008;152:607–11. 4. Aziz HF, Martin JB, Moore JJ. The pediatric disposable end-tidal carbon dioxide detector role in endotracheal intubation in newborns. J Perinatol 1999;11:0–113. 5. Leone TA, Lange A, Rich W, Finer NN. Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Pediatrics 2006;118:e202–4. 6. Finer NN, Rich W, Wang C, Leone TA. Airway obstruction during mask ventilation of very low birth weight newborns during neonatal resuscitation. Pediatrics 2009;123:865–9. 7. Schmolzer GM, Dawson JA, Kamlin CO, O’Donnell Morley CJ, Davis PG. Airway obstruction and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed 2011;96:254–7. 8. Hawkes GA, O’Connell BJ, Livingston V, Hawkes CP, Ryan CA, Dempsey EM. Efficacy and user preference of two CO2 detectors in an infant mannequin randomized crossover trial. Eur J Pediatr 2013. S00431-013 2057-9. 9. Katheria A, Rich W, Finer NN. Electrocardiogram provides a continuous heart rate faster than oximetry during neonatal resuscitation. Pediatrics 2012;130:e1177–81. 10. Gandhi B, Rich W, Finer NN. Time to achieve stable pulse oximetry values in VLBW infants in the delivery room. Resuscitation 2012;84:970–3. 11. Gandhi B, Rich W, Finer NN. Achieving targeted pulse oximetry values in preterm infants in the delivery room. J Pediatr 2013. S0022-3476(13)00034-6.

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Pedi-cap color change precedes a significant increase in heart rate during neonatal resuscitation.

Heart rate is the most important indicator of infant well-being during neonatal resuscitation. The Nellcor Pedi-Cap turns gold when exposed to exhaled...
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