Post Operative Pulmonary Air Leak
Conditions
Keywords
dextrose, air leak, lung resection, pleurodesis
Brief summary
A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. For most patient, an air leak will self-resolve by maintaining a drainage catheter in the chest for a prolonged period. However, for some patients, additional measures are required to help seal the affected tissue. Known strategies for managing post-operative air leak include placing one-way valves, surgical revision, and chemical pleurodesis. Chemical pleurodesis involves injecting an irritant through the chest drainage catheter to promote sealing of the leaking lung tissue. While many agents exist for chemical pleurodesis, a relatively new method for treating an air leak is by using dextrose solution. Dextrose is appealing due to low cost and availability. Dextrose solution has shown some efficacy in other countries and undergone Phase 1 clinical investigation in Canada to show its safety and dosing recommendations. In this study, our aim is to compare the effectiveness of using dextrose solution for treating post-operative air leak compared to usual care with chest tube drainage alone.
Interventions
DRUG50% Dextrose Pleurodesis
A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine
OTHERStandard of Care Chest Drainage
maintenance of post operative pulmonary drain without additional intervention
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who have undergone lung resection * Persistent post-operative air leak \>24 hours after surgery with air leak \>20 mL/min
Exclusion criteria
* pregnant patients * incarcerated patients * patients with early post-operative complications * hemodynamic instability * need for mechanical ventilator support * high volume chest tube output (\>750 mL over 24h)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to air leak resolution | from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days | air leak \<20mL/min as measured by digital tracking atrium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest tube duration | from randomization until chest tube removal, assessed up to 30 days | time until chest tube removal |
| Hospital Length of Stay | from randomization until hospital discharge, assessed up to 30 days | time until patient discharge |
| Adverse Events | from randomization through 30 days post-procedure | occurrence of complications including respiratory failure, pneumonia, and fever |
Contacts
CONTACTJacob F Woodroof, MD
PRINCIPAL_INVESTIGATOROlugbenga Okusanya, MD
Thomas Jefferson University
Outcome results
None listed