NCT02168387

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (CHFO) is more successful at removing mucus than medications that thin out the mucus.

Detailed description

Both of these therapies (CHFO and medication) are currently used in the Pediatric Intensive Care Unit and Pediatric Cardiac Intensive Care Unit. This research study is being done because the investigator is trying to learn if the mechanical removal of mucus with CHFO will effectively re-inflate the collapsed area of lung. Specifically, the study team will determine if CHFO can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood. One of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine). Thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the CHFO as compared with medications that thin out the mucus. CHFO and all the medications used in this study are part of the standard of care for atelectesis. However, there is no information on which combination works best and no one agrees that one approach is more effective than another. Usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.

Conditions

• Atelectasis

Interventions

Type	Name	Description
DEVICE	continuous high frequency oscillator (CHFO)
DRUG	Acetylcysteine
DRUG	dornase alfa

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2014-06-20
• Last updated: 2015-03-03
• Results posted: 2015-03-03