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Completed

NCT Number: NCT02376218

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

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.

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Key information

Conditions

Pulmonary Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic 50% dextrose pleurodesis

Drug

Intrapleural administration of 180ml of hypertonic dextrose solution.

Primary outcomes

  1. Air leak cessation

    Time frame: 48 hours after time of initial injection of 50% glucose solution

    air leak <20 cc/min for 4 hours or more

Secondary outcomes

  1. Time to air leak cessation

    Time frame: 30-day post-operative period

  2. Time to chest tube removal

    Time frame: 30-day post-operative period

  3. Length of hospitalization

    Time frame: 30-day post-operative period

  4. Postoperative complications

    Time frame: 30-day post-operative period

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: PLUG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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