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

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.

Study Overview

• Status: Completed
• Conditions: Atelectasis
• Intervention / Treatment: Drug: Acetylcysteine; Device: continuous high frequency oscillator (CHFO); Drug: dornase alfa

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Acetylcysteine; Drug: dornase alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Atelectasis	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).	after 48 hours of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Capnography (Vd/Vt)	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.	baseline and 48 hours
Change in Quantity and Quality of Suctioned Mucus		baseline and 48 hours

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ira Cheifetz, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: atelectasis; acetylcysteine; continuous high frequency oscillator; dornase alfa
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: Pro00026503