Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.

Study Overview
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Brief Summary
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It is common practice to leave a chest drainage catheter after lung surgical resections to manage air leaks. The air leakage will usually stop in the initial postoperative days, but in a few patients, it will last for a longer period of time, preventing the removal of the chest tube that can lead to patient discomfort, increased likelihood to develop postoperative complications and longer length of hospital stay. Pleurodesis is an effective method to address postoperative air leak which consists in injecting an irritating solution into the chest cavity. This is not performed regularly after lung resections for different reasons including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar glucose solution have been used for years with good results in some Asian countries because of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the postoperative period remains to be defined.

Official Title
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Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.

Conditions
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Pulmonary Surgical Procedures

Intervention / Treatment
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* Drug: Hypertonic 50% dextrose pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older at the time of surgery Having undergone a simple lung lobectomy for malignancy, primary or metastatic Procedure performed through thoracotomy, sternotomy or video-assisted thoracic surgery (VATS), and associated or not to mediastinoscopy, staging thoracoscopy, mediastinal lymph nodes sampling or mediastinal lymph nodes dissection Normally recovery after a surgery performed between 12 and 24 hours earlier Exclusion Criteria: High amount of liquid drainage from chest tube (>500 cc in the last 8 hours) Minimal air leak (<20 cc/min in one of the last 4 hours) Large air leak (>500 cc/min in one of the last 4 hours) History of previous ipsilateral thoracotomy, lung resection, rib fracture, chest trauma, or lung/thoracic infection Diabetes or hyperglycemia Immunity disorders Allergy to local anaesthetics Hemodynamic instability Need for respiratory support Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic 50% dextrose pleurodesis<br> | Drug: Hypertonic 50% dextrose pleurodesis<br>* Intrapleural administration of 180ml of hypertonic dextrose solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air leak cessation | air leak <20 cc/min for 4 hours or more | 48 hours after time of initial injection of 50% glucose solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to air leak cessation |  | 30-day post-operative period | 
| Time to chest tube removal |  | 30-day post-operative period | 
| Length of hospitalization |  | 30-day post-operative period | 
| Postoperative complications | number of participants with one of the following: o Hyperglycemia o De novo atrial fibrillation o Pneumonia o Empyema o Thromboembolic disorders o Confusion o Need for discharge with chest tube o Recurrent pneumothorax o Need for chest tube reinsertion o Death | 30-day post-operative period |