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

Not Applicable

Completed

• Conditions: Pulmonary Surgical Procedures
• Interventions: Drug: Hypertonic 50% dextrose pleurodesis

• Registration Number: NCT02376218
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Study Start: 2015-04
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypertonic 50% dextrose pleurodesis	Hypertonic 50% dextrose pleurodesis	-

Primary Outcome Measures

Name	Time	Method
Air leak cessation	48 hours after time of initial injection of 50% glucose solution	air leak \<20 cc/min for 4 hours or more

Secondary Outcome Measures

Name	Time	Method
Time to chest tube removal	30-day post-operative period
Time to air leak cessation	30-day post-operative period
Length of hospitalization	30-day post-operative period
Postoperative complications	30-day post-operative period	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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada