Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

Completed · Phase 2

Conditions studied: Respiratory Failure

In brief

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 pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population is associated with injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator and/or self-removal of breathing tubes. Our group has developed and validated a nurse-implemented sedation algorithm (set of specific instructions) to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs.

Key facts

Study ID

NCT00142766

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

245

Starts

2004-02-01

Expected to finish

2007-03-01

Last updated by the study team

2015-10-07

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Intubated and mechanically ventilated
• Pulmonary disease

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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