Phase 4
N=39
Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT02168387 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Mar 2015
Primary outcome: Primary: Improvement of Atelectasis — 6; 7; 3; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- continuous high frequency oscillator (CHFO) (Device); Acetylcysteine (Drug); dornase alfa (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement of Atelectasis |
6; 7; 3; 6; 4; 3 | — |
| SECONDARY Change in Capnography (Vd/Vt) |
-0.04; 0.03 | — |
| SECONDARY Change in Quantity and Quality of Suctioned Mucus |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Informed consent from parent or legal guardian.
- Age < 18 years and admitted to the PICU or PCICU.
- Conventionally ventilated.
- Mucolytics are being initiated by clinical team for treatment of atelectasis.
- Endotracheal tube ≥ 3.5 mm internal diameter.
Exclusion Criteria
- Receiving chronic mucolytic or continuous high frequency oscillation therapy.
- Clinically significant pleural effusion.
- Status post cardiothoracic surgery with open chest.
- Pneumothorax.
- Pulmonary hemorrhage.
- Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).
Data sourced from ClinicalTrials.gov (NCT02168387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.