Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
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|ClinicalTrials.gov Identifier: NCT02168387|
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atelectasis||Device: continuous high frequency oscillator (CHFO) Drug: Acetylcysteine Drug: dornase alfa||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: continuous high frequency oscillator (CHFO)
Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
Device: continuous high frequency oscillator (CHFO)
Active Comparator: medication
Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
Drug: dornase alfa
- Improvement of Atelectasis [ Time Frame: after 48 hours of therapy ]
An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:
0 Complete resolution of collapse
- Partial collapse of 1 segment or lobe
- Partial collapse of ≥ 2 segments or lobes
- Complete collapse of 1 segment or lobe
- Complete collapse of ≥ 2 segments or lobes
In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation).
- Change in Capnography (Vd/Vt) [ Time Frame: baseline and 48 hours ]The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.
- Change in Quantity and Quality of Suctioned Mucus [ Time Frame: baseline and 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168387
|Principal Investigator:||Ira Cheifetz, MD||Duke University|