Comparing two methods of lung ventilation during lung cancer surgery
Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery: "Open Lung" Approach With Individualized Level of Positive End-expiratory Pressure Titrated According to the Best Lung Compliance, Versus "Standard" Care: a Randomized Controlled Trial
This study is testing two different ways of helping patients breathe during lung cancer surgery to see which method works better for keeping their lungs safe and improving recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05525312 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates two different strategies for one-lung ventilation (OLV) during lung resection surgery for cancer patients. The study aims to determine the effectiveness of an 'open-lung' protective ventilation strategy, which adjusts positive end-expiratory pressure (PEEP) based on individual patient characteristics, compared to a standard PEEP approach. By measuring transpulmonary pressure using an esophageal catheter, the trial seeks to improve oxygenation and reduce respiratory complications associated with OLV. The findings could provide insights into optimizing ventilation strategies for better surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for lung cancer resection surgery.
Not a fit: Patients with non-carcinologic indications for lung resection or severe respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory function and reduced complications for patients undergoing lung cancer surgery.
How similar studies have performed: Previous studies have shown promising results with similar ventilation strategies in other surgical contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To be over 18 years old, * To be able to attend all scheduled visits and to comply with all trial procedures, * To be scheduled for a lung cancer resection surgery (performed by either video-assisted thoracoscopy or thoracotomy). Exclusion Criteria: * Non-carcinologic indication of lung resection (e.g. Lung volume reduction for bullous emphysema reduction, lung abscess), * Bilateral pulmonary resection surgery or history of lung resection surgery, * Lung resection under sternotomy * Non intubated video-assisted thoracoscopy * Robotic thoracic surgery * Contraindication to esophageal catheter (history of esophageal varices, hepatic cirrhosis child ≥ b, esophageal or gastric surgery, thoracic radiotherapy, latex allergy), * ASA (American Society of Anesthesiologists) score ≥ 4, * Chronic obstructive pulmonary disease GOLD III or IV (Forced Expiratory Volume, FEV\<50%), * Uncontrolled asthma (FEV \<50%), * Intracardiac shunt, * Hemoglobinopathy making the SpO2 values invalid, * Heart failure NYHA III or IV, * Documented pulmonary hypertension (Mean Pulmonary Arterial Pressure at rest, mPAP\>20 mmHg), * To be under legal protection, * Unable to read or write, * Lack of informed consent, or unable to give consent, * Refusal to participate in the study, * Pregnancy in progress or planned during the study period, pregnant or nursing women, * Not being affiliated to a French social security system or being a beneficiary of such a system.
Where this trial is running
Montpellier
- Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Hélène Dr DAVID
- Email: h-david@chu-montpellier.fr
- Phone: 06.65.84.95.24
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.