RecruitingPhase 4NCT07461779

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

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


Sponsor

Francisco Andres de la Gala

Enrollment

177 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

DRUGMedicinal gas - oxygen (Nippon Gases 200 bar)

Medicinal gas, compressed. Oxygen 99.5% v/v

DEVICECPAP

Continuous positive pressure

PROCEDUREOxygen therapy according to standard clinical practice

Ambient air connection


Locations(1)

Hospital General Universitario Gregorio Marañón

Madrid, Spain

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NCT07461779