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

Primary Purpose

Atelectasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
continuous high frequency oscillator (CHFO)
Acetylcysteine
dornase alfa
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis focused on measuring atelectasis, continuous high frequency oscillator, acetylcysteine, dornase alfa

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    continuous high frequency oscillator (CHFO)

    medication

    Arm Description

    Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    Change in Quantity and Quality of Suctioned Mucus

    Full Information

    First Posted
    June 18, 2014
    Last Updated
    March 2, 2015
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02168387
    Brief Title
    Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
    Official Title
    Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atelectasis
    Keywords
    atelectasis, continuous high frequency oscillator, acetylcysteine, dornase alfa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous high frequency oscillator (CHFO)
    Arm Type
    Active Comparator
    Arm Description
    Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
    Arm Title
    medication
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    continuous high frequency oscillator (CHFO)
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylcysteine
    Intervention Type
    Drug
    Intervention Name(s)
    dornase alfa
    Primary Outcome Measure Information:
    Title
    Improvement of Atelectasis
    Description
    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).
    Time Frame
    after 48 hours of therapy
    Secondary Outcome Measure Information:
    Title
    Change in Capnography (Vd/Vt)
    Description
    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.
    Time Frame
    baseline and 48 hours
    Title
    Change in Quantity and Quality of Suctioned Mucus
    Time Frame
    baseline and 48 hours

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ira Cheifetz, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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