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

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ClinicalTrials.gov Identifier: NCT02168387
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Atelectasis Device: continuous high frequency oscillator (CHFO) Drug: Acetylcysteine Drug: dornase alfa Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

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



Primary Outcome Measures :
  1. Improvement of Atelectasis [ Time Frame: after 48 hours of therapy ]

    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).



Secondary Outcome Measures :
  1. Change in Capnography (Vd/Vt) [ Time Frame: baseline and 48 hours ]
    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.

  2. Change in Quantity and Quality of Suctioned Mucus [ Time Frame: baseline and 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168387


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ira Cheifetz, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02168387    
Other Study ID Numbers: Pro00026503
First Posted: June 20, 2014    Key Record Dates
Results First Posted: March 3, 2015
Last Update Posted: March 3, 2015
Last Verified: March 2015
Keywords provided by Duke University:
atelectasis
continuous high frequency oscillator
acetylcysteine
dornase alfa
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes