Clinical trial NCT02168387: Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
Official title: Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atelectasis
Keywords: atelectasis
continuous high frequency oscillator
acetylcysteine
dornase alfa
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 39
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Informed consent from parent or legal guardian.
2. Age \< 18 years and admitted to the PICU or PCICU.
3. Conventionally ventilated.
4. Mucolytics are being initiated by clinical team for treatment of atelectasis.
5. Endotracheal tube ≥ 3.5 mm internal diameter.

Exclusion Criteria:

1. Receiving chronic mucolytic or continuous high frequency oscillation therapy.
2. Clinically significant pleural effusion.
3. Status post cardiothoracic surgery with open chest.
4. Pneumothorax.
5. Pulmonary hemorrhage.
6. Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).

Primary outcomes:
measure: Improvement of Atelectasis
timeFrame: after 48 hours of therapy
Secondary outcomes:
measure: Change in Capnography (Vd/Vt)
timeFrame: baseline and 48 hours
measure: Change in Quantity and Quality of Suctioned Mucus
timeFrame: baseline and 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Ira Cheifetz, MD
role: PRINCIPAL_INVESTIGATOR
References: