Effectiveness of Dextrose Pleurodesis for the Management of Post-Operative Air Leak

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients who have undergone lung resection

Persistent post-operative air leak >24 hours after surgery with air leak >20 mL/min

Disqualifiers

pregnant patients

incarcerated patients

patients with early post-operative complications

hemodynamic instability

Trial design

Design model

Parallel

Treatments tested in this trial

  • 50% Dextrose Pleurodesis

    Drug

    A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine

  • Standard of Care Chest Drainage

    Other intervention

    maintenance of post operative pulmonary drain without additional intervention

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Dextrose PleurodesisExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to air leak resolution

air leak \<20mL/min as measured by digital tracking atrium

Time frame
from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days

Secondary outcomes

1

Chest tube duration

time until chest tube removal

Time frame
from randomization until chest tube removal, assessed up to 30 days
2

Hospital Length of Stay

time until patient discharge

Time frame
from randomization until hospital discharge, assessed up to 30 days
3

Adverse Events

occurrence of complications including respiratory failure, pneumonia, and fever

Time frame
from randomization through 30 days post-procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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