Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery
Recruiting now · Phase 4
Conditions studied: Lung Resection Surgery, Anesthesia General
In brief
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.
Key facts
- Study ID
- NCT07461779
- Run by
- Francisco Andres de la Gala
- People needed
- 177
- Starts
- 2025-01-27
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2026-03-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Patients over 18 years old and legally competent
You may not qualify if…
- 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
- Patient refusal to participate
- Prior contralateral thoracic surgery
- Robotic surgery
- Pneumonectomy
- Enrollment in another clinical trial
Where it is running
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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