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

Pulmonary Surgical Procedures Clinical Trial

— PLUG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376218
• Other study ID #: 105807
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: February 8, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Surgical Procedures

Intervention

Drug:
• Hypertonic 50% dextrose pleurodesis
Intrapleural administration of 180ml of hypertonic dextrose solution.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air leak cessation	air leak <20 cc/min for 4 hours or more	48 hours after time of initial injection of 50% glucose solution	No
Secondary	Time to air leak cessation		30-day post-operative period	No
Secondary	Time to chest tube removal		30-day post-operative period	No
Secondary	Length of hospitalization		30-day post-operative period	No
Secondary	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	Yes