Prone and Oscillation Pediatric Clinical Trial
- Conditions
- Paediatric acute respiratory distress syndrome10038716
- Registration Number
- NL-OMON48534
- Lead Sponsor
- ational Heart, Lung and Blood Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
Pediatric patients >=2 weeks of age (>=42 weeks post gestational age) and <18 years of age*Intubated and mechanically ventilated with severe PARDS for <48 hours per PALICC guidelines(chest imaging consistent with acute pulmonary parenchymal disease and OI >=16 or OSI >=12.3). We require two consecutive blood gases meeting severe PARDS criteria (separated by at least 4 hours during which time the clinical team is working to recruit lung volume and optimize the patient*s hemodynamic status per PALICC guidelines).
Perinatal related lung disease
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
Status asthmaticus
Obstructive airway disease (e.g.,bronchiolitis or disease states characterized by either: hypercapnia with FiO2< 0.30, and/or evidence of increased resistance visible on the flow -time scalar, and/or presence of intrinsicPEEP)*Bronchiolitis obliterans
Post Hematopoietic Stem Cell transplant
Post lung transplant
Home ventilator (including noninvasive) or home oxygen dependent
Neuromuscular respiratory failure
Critical airway (e.g., post laryngotracheal surgeryor new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
Facial surgeryor trauma in previous 15 days
Headtrauma, intracranial bleeding
Unstable spine, femur or pelvic fractures
Acute abdominal process
Obesity (2w-2y: weight-for-height z-score >+3 WHO; >2y BMI z score >+2 WHO)
Received either prone positioning or HFOV with current illness, supported on ECMO
Previously enrolled in current study
Family/medical team not providingfull support (patient treatment considered futile)
Enrolled in any other critical care interventional clinical trial concurrently
Known pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of 28-ventilator free days</p><br>
- Secondary Outcome Measures
Name Time Method <p>Non-pulmonary organ dysfunction<br /><br>Interaction between effects body positioning and ventilator mode<br /><br>90-day in-hospital mortality<br /><br>Duration of mechanical ventilation<br /><br>Length of PICU stay</p><br>