N/A
N=8
MetaNeb® Chest X-ray Study
Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT02871258 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. — 1.63; 1.75; 1.25; 1.13 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The MetaNeb® System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hill-Rom
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. |
1.63; 1.75; 1.25; 1.13; 1.13; 1.25 | — |
| SECONDARY Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. |
1.63; 1.75; 1.25; 1.25; 1.25; 1.13 | — |
| SECONDARY Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). |
4; 2; 3; 1; 3; 4 | — |
| SECONDARY Oxygenation Index (SpO2 /FiO2 Ratio). |
267; 275; 275; 278; 313; 275 | — |
| SECONDARY Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. |
3.5; 3.25; 1.94 | — |
| SECONDARY Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. |
7; 1; 0; 7; 1; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02871258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.