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

NCT07461779 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

  • Lung Resection Surgery
  • Anesthesia General

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

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Francisco Andres de la Gala

    lead OTHER

Principal Investigators

  • Francisco de la Gala, MD, PhD · Hospital General Universitario Gregorio Marañón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2026-12-30
Completion
2027-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461779 on ClinicalTrials.gov