Management of BPF (Bronchopleural Fistulae)
Conditions
Keywords
BPF(Bronchopleural fistulae)
Brief summary
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
Detailed description
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.
Interventions
DEVICEtreatment with valves (The Spiration® IBV Valve System)
treat BPF
Sponsors
Olympus Corporation of the Americas
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Unresolved BPF * Not candidate for surgical repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resolution of BPF (Bronchopleural Fistulae) | 6 weeks | expected resolution of BPF (Bronchopleural Fistulae) in three weeks |
| resolutin of BPF | 6 weeks | anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks |
Countries
United States
Outcome results
None listed