"Open-lung" protective ventilation strategy: In the "open-lung" group, the positive end-tidal pressure (PEEP) is titrated to match the best lung compliance. During a "PEEP decrement trial", PEEP is decreased from 20 cmH2O to 4 cmH2O by steps of 2 cmH2O/minute, and the driving the transpulmonary pressure (PTP) is calculated at each level of PEEP. In the "open-lung" group, the targeted PEEP corresponds to the lowest driving PTP during the "PEEP decrement trial", meaning the best lung compliance. Thereafter, the PEEP is set at this level and maintained until extubation.
"Standard" protective ventilation strategy: In the "standard" group, the positive end-tidal pressure (PEEP) is arbitrarily set at 5 cmH2O, since this is the currently recommended level of PEEP, commonly used in control groups of previous clinical trials.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of intraoperative hypoxemia — During the Open-Lung Ventilation (OLV) period A SpO2\<92% while the FiO2 is progressively decreased to 50% according to a standardized algorithm.
Trial sites (1)
Facility
City
Region
Status
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Montpellier
France
Recruiting
More University Hospital, Montpellier trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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