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

NCT ID: NCT02168387

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-07-31

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.

Conditions

Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

continuous high frequency oscillator (CHFO)

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Acetylcysteine

Intervention Type: DRUG

dornase alfa

Intervention Type: DRUG

Interventions

continuous high frequency oscillator (CHFO)

Intervention Type: DEVICE

Acetylcysteine

Intervention Type: DRUG

dornase alfa

Intervention Type: DRUG

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).

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ira Cheifetz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00026503

Identifier Type: -

Identifier Source: org_study_id