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

NCT ID: NCT02376218

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-02-29

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.

Conditions

Pulmonary Surgical Procedures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypertonic 50% dextrose pleurodesis

Group Type: EXPERIMENTAL

Hypertonic 50% dextrose pleurodesis

Intervention Type: DRUG

Intrapleural administration of 180ml of hypertonic dextrose solution.

Interventions

Hypertonic 50% dextrose pleurodesis

Intrapleural administration of 180ml of hypertonic dextrose solution.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Eric Frechette

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

105807

Identifier Type: -

Identifier Source: org_study_id