Prospective, randomized comparison of high-frequency oscillation and conventional ventilation in candidates for extracorporeal membrane oxygenation,☆☆,

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Abstract

Objective: To compare the safety and efficacy of high-frequency oscillation (HFO) with conventional ventilation in the treatment of neonates with respiratory failure. Design: We conducted a multicenter, prospective, randomized trial. Patients were stratified according to pulmonary diagnosis and then were randomly selected for conventional ventilation or HFO. A balanced crossover design offered patients who met criteria of treatment failure a trial of the alternative mode of ventilation. Setting: Four tertiary, level 3 neonatal intensive care units accepting regional referrals for extracorporeal membrane oxygenation. Patients: Neonates were eligible for enrollment if their gestational age was >34 weeks, their birth weight was ≥2 kg, they were <14 days of age, they required fractional inspired oxygen >0.50 and a mean airway pressure >0.98 kPa (10 cm H2O) to support adequate oxygenation, and they required a peak inspiratory pressure >2.9 kPa (30 cm H2O) and a rate >40 breaths per minute to support adequate ventilation. Exclusion criteria were lethal congenital anomalies, profound shock, need for cardiopulmonary resuscitation, and failure to obtain consent. Main results: Of 79 patients studied, 40 were assigned to conventional ventilation and 39 to HFO. Neonates randomly assigned to HFO required higher peak pressure (3.8 ± 0.5 vs 3.3 ± 0.8 kPa, 39 ± 5 vs 34 ± 8 cm H2O; p = 0.004) and more often met extracorporeal membrane oxygenation criteria (67% vs 40%; p = 0.03) at study entry than did those given conventional ventilation. Twenty- four patients (60%) assigned to conventional ventilation met treatment failure criteria compared with 17 (44%) of those assigned to HFO (not significant). Of the 24 patients in whom conventional ventilation failed, 15 (63%) responded to HFO; 4 (23%) of the 17 in whom HFO failed responded to conventional ventilation (p = 0.03). There were no differences between the two groups with respect to outcome, need for extracorporeal membrane oxygenation, or complications. Conclusions: We conclude that HFO is a safe and effective rescue technique in the treatment of neonates with respiratory failure in whom conventional ventilation fails. (J Pediatr 1994;124:447-54)

Section snippets

METHODS

Our study was a multicenter (n = 4) randomized comparison of HFO and conventional ventilation in the management of ECMO candidates. The study protocol was approved by the institutional review boards at each center and by the U.S. Food and Drug Administration. The four centers involved in this study were Egleston Children's Hospital and Grady Memorial Hospital, Atlanta, Ga.; Saint Luke's Regional Medical Center, Boise, Idaho; and Wilford Hall U.S. Air Force Medical Center, San Antonio, Tex.

RESULTS

Between Jan. 1, 1990, and Oct. 31, 1992, we enrolled 81 patients into the study. We dropped two patients from data analysis: one had total anomalous pulmonary venous return diagnosed after he entered the study, and one had Jeune syndrome. Seventy-nine neonates completed the study, 40 in the conventional ventilation group and 39 in the HFO group.

The median age at entry into the study was 29 hours (range 2 to 146 hours), and most of the neonates enrolled were outborn (83%). Fifty-three percent

DISCUSSION

This study shows that HFO improved gas exchange in 63% of the patients in whom conventional ventilation failed. Attempts to use conventional ventilation to rescue patients in whom HFO failed were not as effective; only 23% responded. Similar results were found in the subset of patients who met ECMO criteria. We believe that this study demonstrates that HFO is a useful adjunct to conventional ventilation in the management of neonates with respiratory failure.

Several previous studies have shown

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Opinions expressed are those of the authors and do not reflect those of the U.S. Air Force or the Department of Defense.

☆☆

Reprint requests: Reese H. Clark, MD, Department of Pediatrics, 2040 Ridgewood Dr. N.E., Atlanta, GA 30322.

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