RecruitingNot Applicable

Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.

France120 participantsStarted 2024-03-20

Plain-language summary

During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. The open-lung approach consists in setting a level of PEEP corresponding to the best lung compliance, using an esophageal catheter to measure the transpulmonary pressure. This approach has been effective in laparoscopic surgeries or acute respiratory distress syndrome, but has never been evaluated in thoracic surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of intraoperative hypoxemia

Timeframe: During the Open-Lung Ventilation (OLV) period

Trial details

NCT IDNCT05525312

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-20

Contact for this trial

Hélène Dr DAVID

06.65.84.95.24 h-david@chu-montpellier.fr

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