RecruitingNot ApplicableNCT05525312

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

Sponsor

University Hospital, Montpellier

Enrollment

120 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Diseases

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria19

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.

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Interventions

PROCEDURE"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.

PROCEDURE"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.