Saptharishi Lalgudi Ganesan1, Muralidharan Jayashree1, Sunit Chandra Singhi1,2, Arun Bansal1. 1. 1 Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and. 2. 2 Division of Pediatrics, Medanta, The Medicity, Gurugram, National Capital Region, India.
Abstract
RATIONALE: Although case series describe benefits of airway pressure release ventilation (APRV), this mode of ventilation has not been evaluated against the conventional low-tidal volume ventilation (LoTV) in children with acute respiratory distress syndrome (ARDS). OBJECTIVES: To compare the effect of APRV and conventional LoTV on ventilator-free days in children with ARDS. METHODS: This open-label, parallel-design randomized controlled trial was conducted in a 15-bed ICU. Children aged 1 month to 12 years satisfying the modified Berlin definition were included. We excluded children with air leaks, increased intracranial pressure, poor spontaneous breathing efforts, chronic lung disease, and beyond 24 hours of ARDS diagnosis or 72 hours of ventilation. Children were randomized using unstratified, variable-sized block technique. A priori interim analysis was planned at 50% enrollment. All enrolled children were followed up until 180 days after enrollment or death, whichever was earlier. MEASUREMENTS AND MAIN RESULTS: The trial was terminated after 50% enrollment (52 children) when analysis revealed higher mortality in the intervention arm. Ventilator-free days were statistically similar in both arms (P = 0.23). The 28-day all-cause mortality was 53.8% in APRV as compared with 26.9% among control subjects (risk ratio, 2.0; 95% confidence interval, 0.97-4.1; Fisher exact P = 0.089). The multivariate-adjusted risk ratio of death for APRV compared with LoTV was 2.02 (95% confidence interval, 0.99-4.12; P = 0.05). Higher mean airway pressures, greater spontaneous breathing, and early improvement in oxygenation were seen in the intervention arm. CONCLUSIONS: APRV, as a primary ventilation strategy in children with ARDS, was associated with a trend toward higher mortality compared with the conventional LoTV. Limitations should be considered while interpreting these results. Clinical trial registered with www.clinicaltrials.gov (NCT02167698) and Clinical Trials Registry of India (CTRI/2014/06/004677).
RCT Entities:
RATIONALE: Although case series describe benefits of airway pressure release ventilation (APRV), this mode of ventilation has not been evaluated against the conventional low-tidal volume ventilation (LoTV) in children with acute respiratory distress syndrome (ARDS). OBJECTIVES: To compare the effect of APRV and conventional LoTV on ventilator-free days in children with ARDS. METHODS: This open-label, parallel-design randomized controlled trial was conducted in a 15-bed ICU. Children aged 1 month to 12 years satisfying the modified Berlin definition were included. We excluded children with air leaks, increased intracranial pressure, poor spontaneous breathing efforts, chronic lung disease, and beyond 24 hours of ARDS diagnosis or 72 hours of ventilation. Children were randomized using unstratified, variable-sized block technique. A priori interim analysis was planned at 50% enrollment. All enrolled children were followed up until 180 days after enrollment or death, whichever was earlier. MEASUREMENTS AND MAIN RESULTS: The trial was terminated after 50% enrollment (52 children) when analysis revealed higher mortality in the intervention arm. Ventilator-free days were statistically similar in both arms (P = 0.23). The 28-day all-cause mortality was 53.8% in APRV as compared with 26.9% among control subjects (risk ratio, 2.0; 95% confidence interval, 0.97-4.1; Fisher exact P = 0.089). The multivariate-adjusted risk ratio of death for APRV compared with LoTV was 2.02 (95% confidence interval, 0.99-4.12; P = 0.05). Higher mean airway pressures, greater spontaneous breathing, and early improvement in oxygenation were seen in the intervention arm. CONCLUSIONS: APRV, as a primary ventilation strategy in children with ARDS, was associated with a trend toward higher mortality compared with the conventional LoTV. Limitations should be considered while interpreting these results. Clinical trial registered with www.clinicaltrials.gov (NCT02167698) and Clinical Trials Registry of India (CTRI/2014/06/004677).
Authors: Michael A Matthay; Rachel L Zemans; Guy A Zimmerman; Yaseen M Arabi; Jeremy R Beitler; Alain Mercat; Margaret Herridge; Adrienne G Randolph; Carolyn S Calfee Journal: Nat Rev Dis Primers Date: 2019-03-14 Impact factor: 52.329
Authors: Eliotte L Hirshberg; Michael J Lanspa; Juhee Peterson; Lori Carpenter; Emily L Wilson; Samuel M Brown; Nathan C Dean; James Orme; Colin K Grissom Journal: Crit Care Med Date: 2018-12 Impact factor: 7.598