Effect of Apneic Oxygenation of the Non-ventilated Lung During Lung Cancer Surgery.

NCT07393490 | Recruiting

• 1 other identifier: APOXOS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of apneic oxygenation of the non-ventilated lung on local and systemic inflammatory response during lung cancer surgery. Patients undergoing surgical resection of lung cancer often require one-lung ventilation during anaesthesia. This results in alveolar hypoxia accompanied by upregulated expression of inflammatory markers. Apneic oxygenation of the non-ventiladed lung may influence inflammatory processes and oxygenation during surgery. The aim of this study is to evaluate whether apneic oxygenation affects inflammatory markers in lung tissue and postoperative recovery in patients undergoing lung cancer surgery. The study is conducted at a single center and includes adult patients scheduled for elective lung cancer surgery. Data will be collected durig the perioperative period. The results of this study may contribute to improved anaesthetic management and patient outcomes during thoracic surgery.

Conditions

Lung Cancer (Diagnosis)

Keywords

One-lung ventilation; Apneic oxygenation; Inflammatory response; Hif 1 alpha; Interleukin 6; Thoracic anaesthesia

Outcome Measures

Primary Outcomes (2)

• Expression of HIF -1α in lung tissue

  Expression of hypoxia inducible factor 1 alpha (HIF 1α ) in lung tissue will be assessed to evaluate tissue hypoxia in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.

  Intraoperative (during lung cancer surgery)

• Expression of IL-6 in lung tissue

  Expression of interleukin 6 (IL-6) in lung tissue will be assessed to evaluate the local inflammatory response in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.

  Intraoperative (during lung cancer surgery)

Secondary Outcomes (5)

• Changes in leukocyte count

  From preoperative baseline to 24 hours after surgery.

• Changes in neutrophile count

  From preoperative baseline to 24 hours after surgery.

• Changes in arterial oxygen partial pressure (PaO2)

  From preoperative baseline to 24 hours after surgery.

• Changes in arterial carbon dioxide partial pressure (PaCO2)

  From preoperative baseline to 24 hours after surgery.

• Incidence of postoperative complications

  Perioperative

Study Arms (2)

Apneic Oxygenation

EXPERIMENTAL

Patients receive apneic oxygenation of non-ventilated lung during lung cancer surgery.

Procedure: Apnoeic Oxygenation

Control Group

ACTIVE COMPARATOR

Patients receive standard ventilation during lung cancer surgery.

Procedure: Standard Ventilation

Interventions

Apnoeic Oxygenation PROCEDURE

Apneic oxygenation of the non-ventilated lung is applied during lung cancer surgery to maintain oxygenation and decrease inflammatory response while the lung is not mechanically ventilated.

Apneic Oxygenation

Standard Ventilation PROCEDURE

Standard ventilation is applied during lung cancer surgery according to routine clinical practice.

Control Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Patients scheduled to undergo surgical resection of a single lung segment for lung cancer
• Written informed consent provided

You may not qualify if:

• Age younger than 18 years
• Chronic corticosteroid therapy and/or other immunomodulatory treatments
• Severe pulmonary diseases, including:
• Chronic obstructive pulmonary disease classified as GOLD stage 3-4 (Global Initiative for Chronic Obstructive Lung Disease).
• Severe asthma according to GINA classification (Global Initiative for Asthma), step 4.
• Severe interstitial lung disease defined by: Forced vital capacity (FVC) \< 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted, presence of extensive pulmonary fibrosis on computed tomography (CT)
• Surgical procedure expected to last less than 2 hours
• Intraoperative hemodynamic instability, defined as: Mean arterial pressure \< 60 mmHg for more than 30 minutes despite adequate volume resuscitation, requirement for high-dose vasopressor support (norepinephrine \> 0.2 µg/kg/min)
• New-onset intraoperative cardiac arrhythmias
• Significant intraoperative blood loss, defined as the need for transfusion of more than two units of packed red blood cells
• Intraoperative ventilatory instability, defined as: Severe hypoxemia (PaO₂ \< 60 mmHg or SpO₂ \< 85% with FiO₂ 1.0), hypercapnia (PaCO₂ \> 70 mmHg with pH \< 7.2), inability to achieve adequate ventilation.

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

University Hospital Center Osijek

Osijek, 31000, Croatia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hrvoje Vinković, MD, PhD candidate

CONTACT

+385 98 810 375; hrvoje.vinkovic@kbco.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned in parallel to either apneic oxygenation or standard ventilation during lung cancer surgery.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 6, 2026
• Study Start: January 2, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)