PROSpect: Prone and Oscillation Pediatric Clinical Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 27, 2019

Keywords

ClinConnect Summary

PROSpect is a large international study looking for the best way to care for children with severe PARDS (a serious lung problem) who are on a breathing tube. It tests four combinations: lying on the back or lying face down, and using either conventional ventilation (a standard breathing machine) or high-frequency oscillatory ventilation (a different, faster way to help breaths). In total, there are four possible groups. About 600 kids aged from 2 weeks up to 20 years who have severe PARDS and have been on a ventilator for up to 48 hours may be eligible. Key inclusion means they have specific blood gas tests showing severe disease, and they don’t have certain conditions that would exclude them (for example some heart or lung problems or ongoing ECMO).

The main goal is to see whether these approaches give more days alive and off the ventilator within 28 days. Secondary goals include 90-day in-hospital survival, how long children stay in the ICU and hospital, how long they remain on ventilation if they survive, and how their function and quality of life look after PICU discharge. The study uses adaptive randomization, meaning as results come in, more patients may be assigned to the better-performing options. It involves many PICUs worldwide and is not testing a drug or device—just the best combination of position and ventilation to improve recovery. If a therapy isn’t helping, doctors may switch to the other option being studied, and data will be shared with researchers in the future.

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