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RECRUITING
NCT07461779
PHASE4

Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery

Sponsor: Francisco Andres de la Gala

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2025-01-27

Completion Date

2027-03-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Medicinal gas - oxygen (Nippon Gases 200 bar)

Medicinal gas, compressed. Oxygen 99.5% v/v

DEVICE

CPAP

Continuous positive pressure

PROCEDURE

Oxygen therapy according to standard clinical practice

Ambient air connection

Locations (1)

Hospital General Universitario Gregorio Marañón

Madrid, Spain