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

NCT02168387 | Completed Phase 4 Results

• 1 other identifier: Pro00026503
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atelectasis

Keywords

atelectasis; continuous high frequency oscillator; acetylcysteine; dornase alfa

Outcome Measures

Primary Outcomes (1)

• 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 1. Partial collapse of 1 segment or lobe 2. Partial collapse of ≥ 2 segments or lobes 3. Complete collapse of 1 segment or lobe 4. 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 Outcomes (2)

• Change in Capnography (Vd/Vt)

  baseline and 48 hours

• Change in Quantity and Quality of Suctioned Mucus

  baseline and 48 hours

Study Arms (2)

continuous high frequency oscillator (CHFO)

ACTIVE COMPARATOR

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)

medication

ACTIVE COMPARATOR

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

Interventions

continuous high frequency oscillator (CHFO) DEVICE

continuous high frequency oscillator (CHFO)

Acetylcysteine DRUG

medication

dornase alfa DRUG

medication

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Acetylcysteine; dornase alfa

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size in a single center study. Children who were extubated prior to the end of the study were not accounted for, as this was not a primary endpoint.

Results Point of Contact

• Title: Ira M. Cheifetz, MD, FCCM, FAARC
• Organization: Duke University Medical Center

ira.cheifetz@dm.duke.edu

919-681-4080

Study Officials

• Ira Cheifetz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 3, 2015
• Results First Posted: March 3, 2015

Record last verified: 2015-03