Oxygen or low-pressure CPAP applied to the non-ventilated lung during lung resection

Impact of Continuous Oxygen Flow With or Without Airway Pressure in the Non-dependent Lung During One-lung Ventilation on Postoperative Complications in Lung Resection Surgery: A Randomized Controlled Clinical Trial

It tests whether giving oxygen or low-pressure CPAP to the non-ventilated lung during scheduled lung resection can reduce inflammation and postoperative complications in adults.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital General Universitario Gregorio Marañon (other)
• Locations: 1 site (Madrid)
• Trial ID: NCT07461779 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, blinded trial enrolls 177 adults undergoing elective lung resection and one-lung ventilation with a double-lumen tube. Participants are assigned to one of three arms: standard oxygen per routine practice, apneic oxygenation delivered through a probe in the double-lumen tube, or low-pressure CPAP (2 cm H2O with 3–5 L/min O2) via a Mapleson system. Investigators will measure inflammatory mediators in blood and both lungs intraoperatively and 24 hours after surgery, and will follow patients until hospital discharge and again at 30 days. The trial compares effects on inflammatory response, ischemia–reperfusion injury, oxygenation, and postoperative complications.

Who should consider this trial

Good fit: Adults (over 18) scheduled for elective lung resection requiring lung isolation with a double-lumen tube who can provide written informed consent are ideal candidates.

Not a fit: Patients with pulmonary bullae, recent blood transfusion, recent immunosuppressant or corticosteroid therapy, prior contralateral thoracic surgery, pneumonectomy, robotic surgery, pregnancy/breastfeeding, or those enrolled in another trial are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could lower postoperative lung inflammation and related complications and improve oxygenation and recovery after lung resection.

How similar studies have performed: Small prior reports suggest low-pressure CPAP can improve oxygenation during one-lung ventilation, but high-quality randomized data are limited and apneic oxygenation remains relatively untested in large trials.

Eligibility criteria

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

Where this trial is running

Madrid

• Hospital General Universitario Gregorio Marañón — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Francisco de la Gala, MD, PhD — Hospital General Universitario Gregorio Marañón
• Study coordinator: Francisco de la Gala, MD, PhD

Conditions: Lung Resection Surgery, Anesthesia General, Postoperative complications, Thoracic surgery