NCT05525312 Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.
| NCT ID | NCT05525312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Lung Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-03-20 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05525312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05525312 currently recruiting?
Yes, NCT05525312 is actively recruiting participants. Contact the research team at h-david@chu-montpellier.fr for enrollment information.
Where is the NCT05525312 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05525312 clinical trial?
NCT05525312 is sponsored by University Hospital, Montpellier. The trial plans to enroll 120 participants.