MetaNeb® Chest X-ray Study

Hill-Rom

Status: Completed

Conditions: Atelectasis

Treatments: Device: The MetaNeb® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871258

CR-RR2016- 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

The MetaNeb® System Treatment

Other group

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.

Treatment:

Device: The MetaNeb® System