Status:
COMPLETED
Prone Positioning in Pediatric Acute Lung Injury
Lead Sponsor:
National Institute of Nursing Research (NINR)
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Acute Lung Injury
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than tho...
Detailed Description
Multicenter, randomized, controlled clinical trial conducted from August 28, 2001 to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who wer...
Eligibility Criteria
Inclusion
- Age \>42 weeks post-conceptual age and \<18 years of age
- On mechanical ventilation (defined as presence of an endotracheal/tracheostomy tube and currently using ventilator support)
- All of the following in the same 48 hour period:
- acute pulmonary parenchymal disease (i.e., chest radiograph report of diffuse bilateral pulmonary alveolar infiltrates)
- mechanical ventilation for at least 1 hour and anticipated need to continue mechanical ventilation for at least 24 hours
- at least one PaO2/FiO2 ratio \<300 (adjusted for barometric pressure: if altitude \> 1000m, then PaO2/FiO2 \<= 300x(B.P./760), regardless of mean airway pressure)
- functional arterial catheter for blood gas analysis
Exclusion
- Persistent hypotension (defined as systolic blood pressure of 70mmHg+(2x age in years)); i.e. patients requiring either intravenous fluids and/or increases of additional cardiotonic medications every 2 hours
- Active bleeding that requires ongoing blood/fluid volume replacement
- Currently on extracorporeal membrane oxygenation (ECMO)
- Severe chronic lung disease (cystic fibrosis or bronchopulmonary dysplasia)
- Respiratory failure presumed to be the result of cardiac disease
- History of symptomatic or uncorrected congenital heart disease or a right to left intracardiac shunt
- Bone marrow or lung transplant
- Current known diagnosis of any of the following:
- upper airway disease (i.e., tracheitis, tracheomalacia)
- reactive airway disease (receiving beta agonists or acute doses of systemic corticosteroids)
- refractory cerebral hypertension (intracranial pressure \[ICP\] \>20mmHg for 1 hr)
- neuromuscular respiratory failure (chronic assisted ventilation)
- spinal instability (uncleared cervical spine)
- unstable long bone fractures
- Nonpulmonary condition that may be exacerbated by the prone position (for example, osteogenesis imperfecta, craniofacial surgery in the past week)
- Draining abdominal surgical wound
- Pregnancy
- Subject's family/medical team have decided not to provide full support (patient treatment considered futile)
- Enrollment in any other clinical trial within the last 30 days
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00133614
Start Date
August 1 2001
End Date
April 1 2004
Last Update
October 31 2005
Active Locations (1)
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1
Childrens Hospital, Boston
Boston, Massachusetts, United States, 02115