About this trial
The purpose of this study is to analyze the effectiveness of apneic oxygenation and CPAP applied to the non-dependent lung during pulmonary resection surgery in reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications. We will conduct a randomized, controlled, and blinded study in 177 patients with three arms:
* Control Group: Oxygen therapy according to standard clinical practice * Apneic oxygenation group: A probe will be introduced through the lumen of the double-lumen tube (DLT) to administer a continuous source of oxygen without any mechanism that generates airway pressure. * CPAP Group: Continuous positive airway pressure with 3-5 L/min oxygen flow and 2 cm H2O pressure delivered via a Mapleson system.
Inflammatory mediators in blood and in both lungs will be measured intraoperatively and 24 hours after surgery. Patients will be followed from hospital admission until discharge and again 30 days after surgery to evaluate the postoperative course, particularly the occurrence of complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical outcomes.
Eligibility criteria
Qualifiers
Patients of both genders undergoing lung resection surgery in the Thoracic Surgery Department at Hospital General Universitario Gregorio Marañón
Lung isolation using a double-lumen tube (DLT)
Scheduled surgery
Patients able and willing to give written informed consent
Disqualifiers
Patients with evidence of pulmonary bullae
Pregnancy or breastfeeding
Blood transfusion within 10 days prior to surgery
Treatment with immunosuppressants or corticosteroids within 3 months prior to surgery
Trial design
Treatments tested in this trial
- Medicinal gas - oxygen (Nippon Gases 200 bar)
- CPAP
- Oxygen therapy according to standard clinical practice
Treatment groups
Sponsors and collaborators
Francisco Andres de la Gala
Lead sponsor
Hospital General Universitario Gregorio Marañon
Sponsor institution
Instituto de Salud Carlos III
Collaborator