Status:
COMPLETED
Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury
Lead Sponsor:
Boston Children's Hospital
Conditions:
Acute Respiratory Distress Syndrome
Acute Lung Injury
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Lung units which participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units which do not participate in gas exchange (i.e. the derecruited s...
Detailed Description
I. Introduction A. Background Lung units which participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units which do not participate in gas ex...
Eligibility Criteria
Inclusion
- All intubated and mechanically ventilated patients on the Medical-Surgical Intensive Care Unit will be screened for the following inclusion criteria:
- Age: 44 weeks post conceptual age to 18 years
- Acute Lung Injury (ALI): American European Consensus Committee definition of ALI
- PaO2/FiO2\<300 on ABG within past 6 hours,
- Acute onset of bilateral infiltrates on chest radiograph, and
- No evidence of left atrial hypertension
- Sedation: Must be receiving neuromuscular blockade or demonstrating apnea due to sedation
- Arterial line must be present
- Conventional mechanical ventilation
- Current PEEP levels between 5 and 15 cm H2O
Exclusion
- Meets the above criteria for ALI for \> 72 hours
- Active hemodynamic instability
- Prematurity (birth at post-conceptual age \<37 weeks)
- Clinically recognized airways disease (including viral bronchiolitis)
- Uncuffed endotracheal tube in place
- Congenital heart disease
- Hemodynamically significant heart disease
- Congenital diaphragmatic hernia
- Recent (past 2 months) history of intrathoracic instrumentation (e.g., orthopedic instrumentation, cardiac pacemaker, thoracostomy)
- Pulmonary fibrosis
- Restrictive lung disease (other than acute lung injury/ARDS)
- Cystic fibrosis
- Severe pulmonary hypertension
- Severe brain injury with no intracranial pressure monitor or external ventricular drain in place
- Extra-corporeal life support
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00830284
Start Date
November 1 2008
End Date
December 1 2012
Last Update
July 29 2019
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115