A pilot randomized controlled trial of EKG for neonatal resuscitation

Background
The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG) affects clinical interventions in the delivery room.
Objective
To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.
Design/Methods
Forty (40) premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733) who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.
Results
There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001). Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.
Conclusion(s)
EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other interventions, but this needs further study.

背景
美国儿科学会（American Academy of Pediatrics）第七版新生儿复苏项目推荐，对需要复苏的新生儿使用心脏监护仪（cardiac monitor）。此前已有研究证实，心电图（electrocardiogram, EKG）心率可早于脉搏血氧仪（pulse oximeter）测得的脉搏率获取。截至目前，尚无研究探讨心电图心率的可及性对产房临床干预措施的影响。

研究目的
明确向临床团队提供心电图心率数值与波形，是否会对早产儿病情稳定阶段的生理指标及相关临床干预措施产生影响。

设计与方法
本研究纳入40名参与神经监测研究（Neu-Prem试验：NCT02605733）且配置有心电图监护仪的早产儿，按随机分组原则将临床团队是否可获取床边心电图监护仪的心率信息分为两组。通过数据采集系统每2秒记录一次心率、血氧饱和度、吸入氧分数（FiO2）及平均气道压，将数据以30秒为周期取平均值，采用双侧t检验（two-tailed t-test）分析组间差异。本研究分析的临床干预指标包括：首次调整吸入氧分数的时间、首次正压通气（positive pressure ventilation）的实施时间、首次提升气道压的时间及首次气管插管（intubation）的实施时间。

研究结果
尽管非盲组可在66±20秒时获取可见心率，而盲法组的获取时间为114±39秒（p < 0.0001），但两组在各项临床干预的启动时间上均无显著统计学差异。出生前2分钟内，脉搏血氧仪测得的脉搏率低于心电图心率，但该差异未达到统计学显著性。

结论
在早产儿病情稳定阶段，心电图可提供早于脉搏血氧仪的更准确心率，从而实现更早的临床干预。非盲心电图组的各项干预措施启动时间均早于盲法组，但在本小样本试验中该差异未达到统计学显著性。相较于先放置脉搏血氧仪，更早放置心电图监护仪可能会对其他临床干预措施产生影响，该结论仍需进一步研究验证。