PROSpect: Prone and Oscillation Pediatric Clinical Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 27, 2019

Keywords

ClinConnect Summary

PROSpect is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV). About 60 pediatric intensive care units (PICUs), two thirds U.S. and one third international, with at least 5 years of experience with prone positioning and HFOV in the care of pediatric patients with severe Pediatric Acute Respiratory Distress Syndrome (PARDS), that can provide back-up extracorporeal membrane oxygenation (ECMO) support, are participating. Eligible consecutive subj...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Intubated and mechanically ventilated with high moderate-severe PARDS for \<48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥12 or OSI ≥10). We require two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume). A second blood gas is not required for OI ≥16.
• Exclusion criteria:
• • Perinatal related lung disease
• • Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
• • Respiratory failure explained by cardiac failure or fluid overload
• • Cyanotic heart disease
• • Cardiomyopathy
• • Unilateral lung disease
• • Primary pulmonary hypertension
• • Intubated for status asthmaticus
• • Obstructive airway disease (e.g., Severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 \<0.30 and/or evidence of increased resistance visible on the flow - time scalar and/or presence of intrinsic PEEP)
• • Active air leak
• • Bronchiolitis obliterans
• • Post hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at time of meeting inclusion criteria; spending more than four days in the PICU prior to intubation; supported on or with immediate plans for renal replacement therapies; with two or more allogeneic transplants; who relapsed after the transplant; or with diffuse alveolar hemorrhage
• • Post lung transplant
• • Home ventilator dependent with baseline Oxygen Saturation Index (OSI) \>6
• • Neuromuscular respiratory failure
• • Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
• • Facial surgery or trauma in previous 2 weeks
• • Head trauma (managed with hyperventilation)
• • Intracranial bleeding
• • Unstable spine, femur or pelvic fractures
• • Open abdomen
• • Currently receiving more than 6 consecutive hours of either prone positioning or HFOV
• • Supported on ECMO during the current admission
• • Family/medical team not providing full support (patient treatment considered futile)
• • Previously enrolled in current study
• • Enrolled in any other interventional clinical trial not approved for co-enrollment
• • Known pregnancy