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

Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168387
• Other study ID #: Pro00026503
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2014
• Last updated: March 2, 2015
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Device:
• continuous high frequency oscillator (CHFO)

Drug:
• Acetylcysteine

• dornase alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Change in Quantity and Quality of Suctioned Mucus		baseline and 48 hours	No