Conventional Mechanical Ventilation Versus High-frequency Oscillatory Ventilation for Congenital Diaphragmatic Hernia: A Randomized Clinical Trial (The VICI-trial). Issue 5 (May 2016)

• Record Type: Journal Article
• Authors: Snoek, Kitty G.; Capolupo, Irma; van Rosmalen, Joost; Hout, Lieke de Jongste-van den; Vijfhuize, Sanne; Greenough, Anne; Wijnen, René M.; Tibboel, Dick; Reiss, Irwin K.M.
• Other Names: collaborator.
• Is Part Of: Annals of surgery. Volume 263:Issue 5(2016:May)
• Page Start: 867
• Page End: 874
• Publication Date: 2016-05
• Subjects: congenital diaphragmatic hernia -- conventional mechanical ventilation -- high-frequency oscillation; Surgery -- Periodicals; 617.005
• DOI: 10.1097/SLA.0000000000001533
• Languages: English
• ISSNs: 0003-4932

Abstract

Abstract : Supplemental Digital Content is available in the text Abstract : Objectives: To determine the optimal initial ventilation mode in congenital diaphragmatic hernia. Background: Congenital diaphragmatic hernia is a life-threatening anomaly with significant mortality and morbidity. The maldeveloped lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of bronchopulmonary dysplasia (BPD) and chronic respiratory morbidity. Methods: An international, multicenter study (NTR 1310), the VICI-trial was performed in prenatally diagnosed congenital diaphragmatic hernia infants (n = 171) born between November 2008 and December 2013, who were randomized for initial ventilation strategy. Results: Ninety-one (53.2%) patients initially received conventional mechanical ventilation and 80 (46.8%) high-frequency oscillation. Forty-one patients (45.1%) randomized to conventional mechanical ventilation died/ had BPD compared with 43 patients (53.8%) in the high-frequency oscillation group. An odds ratio of 0.62 [95% confidence interval (95% CI) 0.25–1.55] ( P = 0.31) for death/BPD for conventional mechanical ventilation vs high-frequency oscillation was demonstrated, after adjustment for center, head-lung ratio, side of the defect, and liver position. Patients initially ventilated by conventional mechanical ventilation were ventilated for fewer days ( P = 0.03), less often needed extracorporeal membrane oxygenation support ( P = 0.007), inhaled nitric oxide ( P = 0.045), sildenafil ( P = 0.004), had a shorter duration of vasoactive drugs ( P = 0.02), and less often failed treatment ( P = 0.01) as compared with infants initially ventilated by high-frequency oscillation. Conclusions: Our results show no statistically significant difference in the combined outcome of mortality or BPD between the 2 ventilation groups in prenatally diagnosed congenital diaphragmatic hernia infants. Other outcomes, including shorter ventilation time and lesser need of extracorporeal membrane oxygenation, favored conventional ventilation.