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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Surgical Procedures
• Intervention / Treatment: Drug: Hypertonic 50% dextrose pleurodesis

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypertonic 50% dextrose pleurodesis	Drug: Hypertonic 50% dextrose pleurodesis; Intrapleural administration of 180ml of hypertonic dextrose solution.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 105807