Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lu… (NCT07461779) | Clinical Trial Compass
RecruitingPhase 4
Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery
Spain177 participantsStarted 2025-01-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.