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