Clinical trial NCT02376218: Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
Official title: Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Surgical Procedures
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Air leak cessation
timeFrame: 48 hours after time of initial injection of 50% glucose solution
Secondary outcomes:
measure: Time to air leak cessation
timeFrame: 30-day post-operative period
measure: Time to chest tube removal
timeFrame: 30-day post-operative period
measure: Length of hospitalization
timeFrame: 30-day post-operative period
measure: Postoperative complications
timeFrame: 30-day post-operative period
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: