Back to resultsMetaNeb® Chest X-ray Study
Primary Purpose
Atelectasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The MetaNeb® System
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis
Eligibility Criteria
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
Sites / Locations
- Hoag Memorial Hospital Presbyterian
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
The MetaNeb® System Treatment
Arm Description
Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment.
Outcomes
Primary Outcome Measures
Chest x-ray score improvement at Day 2 (approximately 48) hours after initiation of therapy with The MetaNeb® System.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02871258
Brief Title
MetaNeb® Chest X-ray Study
Official Title
Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
August 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The MetaNeb® System Treatment
Arm Type
Other
Arm Description
Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment.
Intervention Type
Device
Intervention Name(s)
The MetaNeb® System
Primary Outcome Measure Information:
Title
Chest x-ray score improvement at Day 2 (approximately 48) hours after initiation of therapy with The MetaNeb® System.
Time Frame
Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MetaNeb® Chest X-ray Study
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