Trial intelligence / Profile preview

Oxygen Flow in Non-dependent Lung During One-lung Ventilation in Lung Resection Surgery

NCT07461779Phase 4

Key facts

Status: Recruiting
Start: Jan 2025
Primary completion: Dec 2026
Countries: 1
Modality: Inhalation Devices

Drugs: oxygen
Conditions: hypoxemiaischemia-reperfusion injury (IRI)postoperative complications

Overview

Phase 4, randomised, double-blind trial of oxygen in hypoxemia, ischemia-reperfusion injury (IRI) and postoperative complications (3 arms). Primary endpoint: Postoperative complications up to 30 days. Started Jan 2025; status: recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

Control group
Oxygen therapy according to standard clinical practice
CPAP Group
CPAP with 3-5 L/min oxygen and 2 cmH2O pressure
APNEIC OXYGENATION group
Continuous flow of oxygen without airway pressure

Who it enrols

Adult patients undergoing scheduled lung resection surgery with lung isolation using a double-lumen tube, excluding those with pulmonary bullae, recent blood transfusions, or recent immunosuppressant/corticosteroid treatment.

Endpoints

Primary

Postoperative complicationsUp to 30 days

Secondary

Gas exchange and acid-base balance24 hours
Degree of interference with surgical exposureEnd of surgery
Incidence of postoperative pulmonary complicationsUp to 30 days
Special Care Units stayUp to 30 days
Readmisions to Special Care UnitsUp to 30 days
Hospital StayUp to 30 days
Hospital readmissionUp to 30 days
Inflammatory biomarkers in blood and bronchoalveolar lavagesUp to 24 hours

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