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

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.

• Authors: Kitty G Snoek, Irma Capolupo, Joost van Rosmalen, Lieke de Jongste-van den Hout, Sanne Vijfhuize, Anne Greenough, René M Wijnen, Dick Tibboel, Irwin K M Reiss, CDH EURO Consortium
• Journal: Annals of surgery (Ann Surg) Vol. 263 Issue 5 Pg. 867-74 (May 2016) ISSN: 1528-1140 [Electronic] United States
• PMID: 26692079 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Extracorporeal Membrane Oxygenation
• Female
• Hernias, Diaphragmatic, Congenital (complications, diagnosis, mortality, therapy)
• High-Frequency Ventilation
• Humans
• Infant, Newborn
• Male
• Pregnancy
• Prenatal Diagnosis
• Prospective Studies
• Respiration, Artificial (methods)
• Survival Rate
• Treatment Outcome