Apneic oxygenation for the non-ventilated lung during lung cancer surgery.
The Effect of Apneic Oxygenation of the Non-ventilated Lung on the Expression of Hypoxia-inducible Factor-1 Alpha (HIF-1α) and Interleukin-6 (IL-6) in Lung Tissue During Lung Cancer Surgery.
This test will see if giving oxygen to the non-ventilated lung during one-lung ventilation reduces inflammation and helps recovery in adults having lung cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Osijek University Hospital Academic / other |
| Locations | 1 site (Osijek) |
| Trial ID | NCT07393490 on ClinicalTrials.gov |
What this trial studies
This single-center randomized study will enroll 56 adults scheduled for elective lung cancer resection and randomize them to receive apneic oxygenation of the non-ventilated lung or standard management during one-lung ventilation. The team will collect lung tissue and blood samples perioperatively to measure local and systemic inflammatory markers, including HIF-1 alpha and interleukin-6, and will monitor intraoperative oxygenation. Clinical outcomes and postoperative recovery measures will be recorded during the perioperative period. Findings will be compared between the apneic oxygenation and control groups to determine physiological and short-term recovery effects.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective surgical resection of a single lung segment for lung cancer who can give informed consent and do not meet exclusion criteria are eligible.
Not a fit: Patients with severe pulmonary disease (e.g., GOLD 3-4 COPD, severe asthma, advanced interstitial lung disease), those on chronic immunomodulatory therapy, very short expected surgeries, or those unable to undergo the protocolized perioperative sampling are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce local and systemic inflammation during surgery, improve oxygenation during one-lung ventilation, and lead to faster or safer postoperative recovery.
How similar studies have performed: Prior anesthesia studies have shown apneic oxygenation can improve oxygenation during apnea, but its effects on inflammatory markers during one-lung ventilation are largely unproven and remain novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Patients scheduled to undergo surgical resection of a single lung segment for lung cancer * Written informed consent provided Exclusion Criteria: * 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.
Where this trial is running
Osijek
- University Hospital Center Osijek — Osijek, Croatia (Recruiting)
Study contacts
- Study coordinator: Hrvoje Vinković, MD, PhD candidate
- Email: hrvoje.vinkovic@kbco.hr
- Phone: +385 98 810 375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.