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

NCT07461779 | Recruiting Phase 4

• 1 other identifier: ECAOI-22
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative complications; Thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  To compare the proportion of patients in each grade of the revised Clavien-Dindo classification for thoracic surgery across the three study groups

  Up to 30 days after intervention

Secondary Outcomes (9)

• Gas exchange and acid-base balance

  Intraoperative period and 24 hours

• Degree of interference with surgical exposure (Surgeon Satisfaction Scale on Oxygen Therapy Interference, 1-5)

  Surgery duration; assessed at end of surgery

• Incidence of postoperative pulmonary complications

  Up to 30 days after intervention

• Special Care Units stay

  Up to 30 days after intervention

• Readmisions to Special Care Units

  Up to 30 days after intervention

Study Arms (3)

Control group

ACTIVE COMPARATOR

Oxygen therapy according to standard clinical practice. The nondependent lung (surgical) will be connected to ambient air by opening the lumen of the double-lumen tube (DLT) directed towards that lung

Procedure: Oxygen therapy according to standard clinical practice

CPAP Group

EXPERIMENTAL

Continuous positive airway pressure with 3-5 L/min oxygen and 2 cmH2O pressure delivered via a Mapleson system

Device: CPAP

APNEIC OXYGENATION group

EXPERIMENTAL

A probe will be introduced through the lumen of the DLT to deliver a continuous flow of oxygen without any mechanism that generates airway pressure

Drug: Medicinal gas - oxygen (Nippon Gases 200 bar)

Interventions

Medicinal gas - oxygen (Nippon Gases 200 bar) DRUG

Medicinal gas, compressed. Oxygen 99.5% v/v

APNEIC OXYGENATION group

CPAP DEVICE

Continuous positive pressure

CPAP Group

Oxygen therapy according to standard clinical practice PROCEDURE

Ambient air connection

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Francisco Andres de la Gala: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco de la Gala, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco de la Gala, MD, PhD

CONTACT

+34915868367; francisco.gala@salud.madrid.org

Ignacio Garutti, MD

CONTACT

+34915868367; ignacio.garutti@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All clinical staff (thoracic surgeons, pulmonologists, ICU physicians, and any other physicians involved in assessing postoperative complications) and laboratory personnel involved in the study will be blinded to the patient's group assignment, except for the anesthesiologist responsible for the case. The sealed randomization envelope will be handed to the anesthesiologist by the operating-room nurse before the start of OLV. Likewise, those responsible for entering data into the database will be blinded to group assignment; the group will be recorded in the database only immediately prior to statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Patients will be randomized into three groups based on the anesthetic technique used: Control Group (oxygen therapy according to standard clinical practice), Intervention Group 1 (apneic oxygenation), and Intervention Group 2 (CPAP). Randomization will be performed using EPIDAT 3.1 program. Randomization codes will be obtained prior to the recruitment of the first patient and will be placed in sealed, sequentially numbered envelopes. The operating-room anesthesiologist will open the envelope for each patient and will prepare the assigned intervention and collect the study data.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: March 10, 2026
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

ES (1)