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

NCT02376218 | Completed

• 1 other identifier: 105807
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  30-day post-operative period

Study Arms (1)

Hypertonic 50% dextrose pleurodesis

EXPERIMENTAL

Drug: Hypertonic 50% dextrose pleurodesis

Interventions

Hypertonic 50% dextrose pleurodesis DRUG

Intrapleural administration of 180ml of hypertonic dextrose solution.

Hypertonic 50% dextrose pleurodesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 3, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

CA (1)