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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02376218
Other study ID # 105807
Secondary ID
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


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
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