Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07461779

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

Led by Francisco Andres de la Gala · Updated on 2026-03-10

177

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

F

Francisco Andres de la Gala

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both genders undergoing lung resection surgery in the Thoracic Surgery Department at Hospital General Universitario Gregorio Mara�f1�n
  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Actively Recruiting

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Research Team

F

Francisco de la Gala, MD, PhD

CONTACT

I

Ignacio Garutti, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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