Spiration IBV® Valve System and Spiration Airway Sizing Kit



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:4/2/2016
Start Date:March 2012
End Date:June 2015
Contact:Melissa Michetti
Email:melissa.michetti@osumc.edu
Phone:6142938000

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The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.

This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks
of the lung, or significant air leaks that are likely to become prolonged air leaks
following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak
present on postoperative day 7 is considered prolonged unless present only during forced
exhalation or cough. An air leak present on day 5 should be considered for treatment if it
is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present
upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
IBV Valve System use is limited to 6 weeks per prolonged air leak.

Inclusion Criteria:

- Unresolved BPF

- Not candidate for surgical repair
We found this trial at
1
site
Columbus, Ohio 43210
?
mi
from
Columbus, OH
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