Status:
COMPLETED
Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Gustavus and Louise Pfeiffer Research Foundation
Conditions:
Respiratory Failure
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pedia...
Detailed Description
We propose a two-year project to pilot test and evaluate an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the PI...
Eligibility Criteria
Inclusion
- Intubated and mechanically ventilated
- Pulmonary disease
Exclusion
- Less than or equal to 2 weeks of age or 42 weeks corrected gestational age
- Greater than 18 years of age
- Intubated and mechanically ventilated for immediate post-operative care and stabilization
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- Critical airway (e.g. post laryngotracheal reconstruction)
- Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
- Neuromuscular respiratory failure
- Spinal cord injury above the lumbar region
- Managed by patient controlled analgesia (PCA)or epidural catheter
- Known allergy to any of the study medications (Morphine,Methadone, Midazolam, Lorazepam)
- Family/Medical team have decided not to provide full support(patient treatment considered futile)
- Previously enrolled into the current study or enrolled in any other sedation clinical trial concurrently or within the last 30 days
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00142766
Start Date
February 1 2004
End Date
March 1 2007
Last Update
October 7 2015
Active Locations (3)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
3
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201