Clinical trial NCT05525312: Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Keywords: Pulmonary resection surgery
One lung ventilation
Positive end-expiratory pressure
Esophageal pressure
Transpulmonary pressure
Lung compliance
Protective ventilation
Hypoxemia
Postoperative complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the "standard" protective ventilation versus an "open lung" protective ventilation protocol during a pulmonary resection surgery
Primary purpose: PREVENTION

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.

Detailed description: Pulmonary resection surgery plays a key role in the treatment of localized lung cancer. During thoracic surgery, lung isolation is necessary. One-lung ventilation (OLV) is associated with frequent intraoperative respiratory complications, hypoxemia or lung injury related to mechanical ventilation. Intraoperative events increase the risk of postoperative complications resulting from either hypoxemia (atrial fibrillation, delirium, acute kidney injury) or lung injury (atelectasis, pulmonary edema, pneumonia, acute respiratory distress syndrome (ARDS)).

During OLV, a protective ventilation strategy is now recommended, including a low tidal volume (VT), using the lowest fraction of inspired oxygen (FiO2) due to the toxicity of high-oxygen concentration, and recruitment maneuvers (RM). But there is no consensus on the level of positive end-tidal pressure (PEEP) to apply. A low level of PEEP increases the risk of alveolar collapse, when a too high level leads to alveolar overdistension and increases lung dead space. The PEEP is usually arbitrary fixed to 5 cmH2O for every patient, which does not take into account the individual characteristics of the patient. Recent clinical trials in thoracic surgery showed that titration of PEEP according to the lowest airway driving pressure \[end-inspiratory plateau pressure - total end-expiratory pressure\], compared to a standard PEEP of 5 cmH2O, increased oxygenation and lung mechanics, and decreased significantly respiratory complications.

The transpulmonary pressure (PTP) is the instantaneous difference between alveolar pressure and pleural pressure. In order to optimize the alveolocapillary gas exchange, the level of PEEP should be titrated until achieving the best lung compliance (CL), defined by the ratio \[(tidal volume) / (driving PTP = end-inspiratory PTP - end-expiratory PTP)\]. As the tidal volume is set on the ventilator, the level of PEEP corresponding to the best CL is the one associated with the lowest driving PTP. The "open lung" strategy consists in setting the level of PEEP according to the best CL, which is an individualized approach, probably more physiologic than the standard care.

The esophageal pressure (PES) measured by an esophageal catheter is a validated estimation of the pleural pressure. Then, the PTP could be approximated by the difference \[airway plateau pressure - PES\]. The placement of an esophageal catheter is safe provided that the use respects contraindications (mainly esophageal disease or varices).

In ARDS, the open lung approach using an esophageal catheter was associated with a better clinical outcome than the standard non-individualized protocol. In laparoscopic surgery, the effects of PEEP on the PTP is also well described. In thoracic surgery, to date, monitoring PES and PTP is not part of the usual care. To our knowledge, only one study described the PTP changes during OLV. In this study, the best PEEP during OLV differed from one patient to another, which goes against the "one size fits all" theory. Thus, the PEEP should be titrated and individualized. Nevertheless, the airway driving pressure is only an approximation of the PTP, since it does not take into account the pleural pressure, which is a non-negligible extra-alveolar factor when talking about patients with lung or pleural diseases. Measuring the driving PTP using an esophageal catheter is certainly more accurate.

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
* 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 outcomes:
measure: The incidence of intraoperative hypoxemia
timeFrame: During the Open-Lung Ventilation (OLV) period
Secondary outcomes:
measure: Hypoxemia events
timeFrame: During the OLV period
measure: The ventilatory parameters
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: The ventilatory parameters
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: The ventilatory parameters
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: The ventilatory parameters
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: Blood gas analysis
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: Blood gas analysis
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: Blood gas analysis
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: Blood gas analysis
timeFrame: T1: baseline, two-lung ventilation, before OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
measure: Intraoperative events related to hypoxemia
timeFrame: During the OLV period
measure: Intraoperative events related to hypoxemia
timeFrame: During the OLV period
measure: Intraoperative events related to hypoxemia
timeFrame: During the OLV period
measure: Intraoperative events related to hypoxemia
timeFrame: During the OLV period
measure: Intraoperative events not only due to hypoxemia
timeFrame: During the OLV period
measure: Postoperative respiratory complications until postoperative day 28
timeFrame: Day 28
measure: Non-respiratory postoperative complications until postoperative day-28 (POD28)
timeFrame: Day 28
measure: The hospital stay
timeFrame: Day 28 and Day 90
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Study officials:
References: