Comparison of 40% Glucose Solution and Autologous Blood Patch Pleurodesis for Postoperative Air Leak After Lung Resections

Summary

Prolonged or persistent air leak (PAL) is one of the most common complications in patients after surgery on the lung parenchyma. Air leaks typically originate from alveolar-pleural fistulas, which can result from surgical manipulation of the lung parenchyma or the bronchial stump after procedures such as lobectomy. Key risk factors for PAL include extensive lung resections such as lobectomy, presence of pleural adhesions, incomplete interlobar fissures, chronic obstructive pulmonary disease (COPD), asthma, emphysema, advanced age, and reduced preoperative lung function, particularly low preoperative FEV1 values.

PAL necessitates extended pleural drainage, leading to significant patient discomfort, pain, and substantial limitations in early postoperative rehabilitation. In patients with pre-existing pulmonary conditions like bronchial asthma or COPD, PAL can markedly worsen clinical status, resulting in severe complications such as infections, pneumonia, pleural empyema, acute respiratory distress syndrome, and even mortality. In extreme cases, PAL may contraindicate chemotherapy, causing significant delays in adjuvant therapy post-surgery. Effective management of PAL can significantly enhance patient quality of life, facilitating a quicker return to normal activities and continuation of systemic treatment.

Moreover, PAL is a leading cause of extended hospitalization, invariably increasing treatment costs. Therefore, the necessity for safe and effective treatment of PAL is justified not only medically but also economically.

Current standards for PAL treatment encompass both surgical and non-surgical methods. The available literature describes various conservative treatments, among which pleurodesis is commonly employed. Non-surgical pleurodesis techniques include the intrapleural administration of the patient's autologous blood or chemical agents such as medical talc, povidone-iodine, or doxycycline.

Intrapleural administration of autologous blood, known as autologous blood patch pleurodesis (ABPP), is widely utilized for the conservative treatment of PAL. This method involves injecting the patient's own blood into the pleural space through an existing chest tube, promoting clot formation and sealing of the air leak. Studies have demonstrated the safety and efficacy of ABPP, with success rates exceeding 80% in sealing air leaks within 48 hours and a low incidence of complications such as fever or empyema.

Another method highlighted in limited scientific literature is the intrapleural administration of a 50% glucose solution. This technique has been primarily reported by authors from Asian countries, such as Japan and Korea, and is not widely adopted in Western centers. Available studies emphasize its effectiveness, with success rates exceeding 80%, and report a lack of complications in patients undergoing pleurodesis with concentrated glucose solutions.

The aim of our study is to compare the effectiveness of a 40% glucose solution with the ABPP. The selection of a 40% glucose solution is due to the unavailability of a 50% glucose solution in the Polish pharmaceutical market.

Potential benefits of effective PAL treatment include improved patient quality of life, reduced hospitalization duration, decreased risk of complications, and lower treatment costs. Prolonged hospitalization and treatment associated with PAL generate significant expenses for the healthcare system. Our study may contribute to significant improvements in treatment outcomes, patient quality of life, and the cost-effectiveness of thoracic surgical procedures. In the long term, this research may also influence the development of new treatment standards and clinical protocols.

Conditions

• Prolonged Air Leak
• Persistent Air Leak

Interventions

PROCEDURE

Autologous blood patch pleurodesis

The intervention in this study is distinguished by the fact that patients are randomized, the dose of both glucose and ABPP is 120 ml, the patient remains in a supine position for 2 hours after administration, the procedure can be repeated at 48-hour intervals, a maximum of 3 times.

PROCEDURE

40% glucose solution pleurodesis

After obtaining informed consent, the patient will lie supine in their room. 30 minutes before the procedure, the patient's capillary blood glucose level will be measured. The patient does not have to fast before the procedure. The nurse will be asked to collect 120 ml of peripheral venous blood from the patient. Then the doctor, assisted by the nurse, will first administer 20 ml of 1% Lignocaine through the pleural drain, and then after about 5-10 minutes, the patient's previously collected venous blood. At the moment of blood administration, the drainage system will be disconnected. Then, the drain will be "injected" with 20 ml of air to avoid clogging the drain. The patient will remain supine for two hours post-procedure, maintaining fasting status. After 30 minutes from the administration of the patient's own blood, the capillary blood glucose level will be measured again. After two hours, the patient, with nursing assistance, may resume normal activities.

Sponsors & Collaborators

• Poznan University of Medical Sciences

  collaborator OTHER

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-22

Primary Completion

2026-12-01

Completion

2027-05-31

Countries

• Poland

Study Locations