MetaNeb® Chest X-ray Study

Study Overview
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Brief Summary
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To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.

Detailed Description
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Study Population: Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results. Duration of treatment: Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.

Official Title
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Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray

Conditions
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Atelectasis

Intervention / Treatment
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* Device: The MetaNeb® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-surgical (thoracic, cardiac or abdominal surgery) Age ≥ 18 years Significant atelectasis by chest x-ray Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure) Signed informed consent Exclusion Criteria: Cause of atelectasis suspected to be infectious or solid mass Requirement for mechanical ventilation Requirement for chronic supplemental oxygen Hemodynamically unstable, as defined by need for vasopressor therapy Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention Contraindication to MetaNeb® therapy (untreated tension pneumothorax) Inability to perform MetaNeb® therapy using a mouthpiece Anticipated hospital discharge within 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The MetaNeb® System Treatment<br>Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. | Device: The MetaNeb® System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest x-ray score improvement at Day 2 (approximately 48) hours after initiation of therapy with The MetaNeb® System. |  | Approximately 48 hours post-initiation of therapy with The MetaNeb® System. |