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Inhaled Nitric Oxide and Gentle Ventilation in the Treatment of Pulmonary Hypertension of the Newborn—A Single-Center, 5-Year Experience

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Inhaled Nitric Oxide and Gentle Ventilation in the Treatment of Pulmonary Hypertension of the Newborn—A Single-Center, 5-Year Experience Original Article &&&&&&&&&&&&&& Inhaled Nitric Oxide and Gentle Ventilation in the Treatment of Pulmonary Hypertension of the Newborn — a Single-Center, 5-Year Experience Anju Gupta, MD, MRCP Shantanu Rastogi, MD oxygenation (ECMO) compared to historical pre-INO period controls (23.9% vs. 12.8%, p<0.01). In the infants treated with GV alone, the MAP Rakesh Sahni, MD dropped from 17.2±4.3 cm H2O at the referral hospital to 12.6±2.4 after Alok Bhutada, MD GV was started in our unit. David Bateman, MD Deepa Rastogi, MD CONCLUSIONS: Arthur Smerling, MD We conclude that INO is an effective and well-tolerated therapy for PH in Jen-Tien Wung, MD infants receiving GV. Journal of Perinatology (2002) 22, 435 – 441 doi:10.1038/sj.jp.7210761 OBJECTIVE: INTRODUCTION To evaluate the effect of inhaled nitric oxide (INO) in pulmonary hypertension of the newborn (PH) in a single center over 5 years using Pulmonary hypertension (PH) of the newborn is a clinical syndrome gentle ventilation (GV), without hyperventilation or induced alkalosis. of varied etiology, mainly involving near-term infants. PH may be primary (PPHN); or secondary to meconium aspiration syndrome METHODS: (MAS), congenital diaphragmatic hernia (CDH), lung hypoplasia, Data from 229 consecutive infants with PH of varied etiology treated with congenital heart disease (CHD), polycythemia, or sepsis. PH is INO and GV, and from 67 infants with meconium aspiration syndrome characterized by hypoxemia secondary to elevated pulmonary (MAS) and primary PH (PPHN) treated with GV alone were reviewed over a vascular resistance and right-to-left shunting of blood across 5-year period (86% outborn). INO was initiated at 25 ppm when PH and foramen ovale and/or ductus arteriosus.1 severe hypoxemia persisted despite maximal optimal ventilation. Hyper- Most published literature describes use of hyperventilation, ventilation or systemic alkalosis were not attempted. induction of alkalosis, neuromuscular blockade, and sedation for treatment of PH.2–4 None of these therapies has shown a significant RESULTS: Mean duration of ventilation was 9.9±14 days (median 6.5 days). Average reduction in mortality or need for extracorporeal membrane mean airway pressure (MAP) dropped from 17.7±4.3 cm H Oatthe oxygenation (ECMO). Currently, most neonatologists use the above 2 approach, which is aggressive, technologically complicated, and more referral hospital to 13.2±2.5 cm H2O(p<0.001) following admission to our unit using conventional settings and GV, before starting INO. Mean traumatic, as opposed to the more traditional and gentler ventilatory approach with permissive hypercapnia, acceptable acidosis, and oxygenation index (OI) dropped from 46.8±24.5 to 22.7±21.4 within 24 2 hours of INO therapy ( p<0.001). Infants with higher baseline pH and adequate oxygenation with preservation of spontaneous respiration. lower baseline OI responded better to INO ( p<0.02). Overall survival was No controlled study to compare either approach is published. One of 72%. Patients with MAS and PPHN had the best response, 92% survived and the recent additions to the armamentarium of treatment for PH is there was a 46% reduction in need for extracorporeal membrane inhaled nitric oxide (INO), which is a selective pulmonary vasodilator that is effective in neonatal animals5 and humans.6–8 INO improves oxygenation and may reduce the need for ECMO.6–8 Department of Pediatrics ( A.G., S.R., R.S., A.B., D.B., D.R., A.S., J.-T.W. ), The Children’s Hospital Several major multicentered, randomized, controlled trials in the of New York, College of Physicians and Surgeons, Columbia University, New York, NY, USA; and United States evaluate the effects of INO in term and near-term Department of Anesthesiology (A.S., J.-T.W.), The Children’s Hospital of New York, College of infants with PH.6–10 Davidson et al. concluded that early use of INO Physicians and Surgeons, Columbia University, New York, NY, USA. improves oxygenation and may reduce the need for ECMO.6 The Address correspondence and reprint requests to Jen - Tien Wung, MD, Department of Pediatrics, Division of Neonatology, The Children’s Hospital of New York, College of Physicians and Neonatal Inhaled Nitric Oxide Study Group (NINOS) trial showed Surgeons, Columbia University, 3959, Broadway BHN 1201, New York, NY 10032, USA. that INO at 20 parts per million (ppm) was well tolerated, reduced Journal of Perinatology 2002; 22:435 – 441 # 2002 Nature Publishing Group All rights reserved. 0743-8346/02 $25 www.nature.com / jp 435 Gupta et al. INO and Gentle Ventilation in the Treatment of PPHN need for ECMO, but did not reduce mortality.8 Kinsella and inspiratory time of 0.5 seconds. If the infant shows excessively labored colleagues studied the effects of INO versus high-frequency spontaneous respiration or the PaCO2 remains above 60 mm Hg, oscillatory ventilation (HFOV), and found that a combination of INO high-frequency positive pressure ventilation (HFPPV) is used by and HFOV was better than either alone.9 Clark et al. used low dose setting the ventilator rate at 100/min, with inspiratory time of INO at 20 ppm for a maximum of 24 hours followed by 5 ppm for 0.3 seconds and PEEP of 0 cm H2O (to account for the inadvertent maximum 96 hours and also found that INO reduced chronic lung PEEP associated with such short expiratory times). In our experience, disease and need for ECMO.10 Because the above trials were infants with little or no evidence of parenchymal disease are more multicentered, the interinstitutional variability in ventilatory likely to respond to HFPPV. Usually most infants settle down with management could significantly confound the outcome measures.11 ventilatory adjustments and a clear airway, and no sedation or In fact, one of the trials reported marked differences in outcome paralysis is required. Occasionally, if an infant is very agitated and among the trial centers, and multiple regression analysis showed that there are no mechanical causes of hypoxia (i.e., endotracheal tube the trial center was an independent predictor of outcome.9 We are block or malposition), minimal sedation with low-dose pheno- reporting our single-center, 5-year experience of INO therapy in a barbital or rarely midazolam is used. Paralysis, opiate infusions, cohort of 229 consecutive infants with severe PH, using a uniform, deliberate respiratory or metabolic alkalosis are not attempted. If the gentle ventilatory strategy, with permissive hypercarbia, no infant fails above management and/or the PaCO2 remains elevated hyperventilation or alkalosis, and avoidance of paralysis.12 (>60 mm Hg), the infant is given a trial on HFOV. Indications for INO Therapy/ECMO MATERIALS AND METHODS Infants with persistent PH and severe hypoxemia, with PaO2 Patient Population <40 mm Hg and preductal oxygen saturation <80%, were started We reviewed the data on all newborn infants admitted to the neonatal on INO therapy at 25 ppm. Methemoglobin levels were monitored intensive care unit at The Children’s Hospital of New York, between before initiating INO, 30 minutes after starting, and then every 6 to May 1994 and April 1999, with clinical and echocardiographic 12 hours to avoid toxicity (>5%). Response to INO was defined as an evidence of PH, i.e., right-to-left shunting at the foramen ovale and/ increase in preductal saturation to above 80% (an increment of at least or ductus arteriosus, deviation of interatrial septum to the left and/or 10%) within an hour of commencing INO therapy. Based on their tricuspid regurgitation. During this period, 241 infants received INO response to INO therapy, infants were categorized into four groups, i.e., therapy for severe PH with various underlying etiologies. Twelve of nonresponders, transient responders, sustained responders, and INO these infants, in whom INO therapy was initiated before transfer to dependents.16 Infants who failed to respond to INO therapy and had our institution, were excluded from the study. Of the remaining 229 persistent PaO2 <40 mm Hg and preductal oxygen saturation <80% infants, 196 (86%) of the infants were outborn and had failed underwent ECMO, if there were no contraindications. maximal ventilatory support before referral for INO therapy and/or ECMO. All infants had an indwelling arterial line and continuous INO Delivery pre- and postductal pulse oximetry. Mean airway pressure (MAP) INO was delivered into the inspiratory limb of the ventilator circuit at was calculated using the formula: [PIPÀPEEP]Â[Ti/(Ti+ a distance of 45 cm upstream from the endotracheal tube. This Te)]+PEEP. Informed consent was obtained from parents before distance allowed adequate mixing of nitric oxide with inhaled gases, initiation of INO therapy. Data from 67 infants with PH due to MAS without allowing prolonged exposure of nitric oxide gas to oxygen and PPHN during the study period, who were treated with gentle and water vapor, which could result in the formation of nitrogen ventilation (GV) alone (and did not require INO), were also dioxide, nitrous acid, and nitric acid. The flow rate of nitric oxide was reviewed. calculated to provide the desired concentration (25 ppm) by using the equation: flow rate of nitric oxide (liters)=desired dose of INO Ventilatory Strategy (ppm)Âventilator flow rate (liters)Änitric oxide concentration in Our unit has successfully used ‘‘gentle mode of ventilation’’ to treat cylinder (ppm). These flow rates were reliable and had been PH for over 25 years.12–14 This mode of ventilation focuses on validated previously by using chemiluminescence analyzer. The gases maintenance of adequate oxygenation with minimization of from the expiratory limb of the circuit were scavenged by the central barotrauma. The principles of this approach are to use low suction system to the atmosphere outside. ventilatory settings while preserving spontaneous respiration to maintain PaO2 between 50 and 70 mm Hg and PaCO2 between 40 Maintenance and Weaning of INO and 60 mm Hg as described before.15 Briefly, time-cycled, pressure- If the infant responded to INO with a significant increase in oxygen limited, constant-flow infant ventilators are used.
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