About this trial
One-lung ventilation (OLV) is required during many thoracic surgical procedures and is associated with reduced functional residual capacity, atelectasis, ventilation-perfusion mismatch, hypoxemia, and potentially ventilator-induced lung injury. Lung-protective ventilation strategies include low tidal volumes, limitation of airway pressures, and positive end-expiratory pressure (PEEP), but the optimal PEEP level during OLV remains uncertain. Fixed PEEP is simple and reproducible but does not account for individual patient characteristics. Body mass index (BMI) is readily available before anesthesia and is associated with respiratory mechanics, making it a pragmatic candidate for simple PEEP individualization.
SIMPLE-PEEP is a prospective, multicenter, pragmatic, open-label, randomized clinical trial including 150 adults undergoing elective pulmonary resection under general anesthesia requiring OLV. Participants will be randomized to either fixed PEEP of 4 cmH2O or BMI-adjusted PEEP calculated as BMI/3 cmH2O. Other key components of lung-protective ventilation will be standardized between groups.
The primary outcome is driving pressure during the first 20 minutes of OLV, assessed at 5, 10, and 20 minutes after OLV initiation. Secondary outcomes include respiratory system compliance and other respiratory mechanics, estimated mechanical power, oxygenation, intraoperative hypoxemia and rescue maneuvers, hemodynamic safety, vasopressor requirements, and exploratory postoperative respiratory outcomes. No investigational medicinal product, additional invasive procedure, or study-specific advanced monitoring is required.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Scheduled thoracic surgery for pulmonary resection requiring general anesthesia and one-lung ventilation.
Written informed consent obtained before any study-specific procedure.
Disqualifiers
Simultaneous participation in another interventional clinical trial that could interfere with the protocol.
Severe hemodynamic instability before the start of the procedure, defined as continuous vasopressor infusion or shock of any etiology.
Severe restrictive lung disease, defined as total lung capacity <50% of predicted or forced vital capacity <50% of predicted.
Body mass index >45 kg/m2.
Trial design
Parallel
Treatments tested in this trial
Fixed PEEP
Procedure/SurgeryFixed PEEP of 4 cmH2O
BMI-adjusted PEEP
Procedure/SurgeryBMI-adjusted PEEP calculated as BMI/3 cmH2O
Treatment groups
Trial outcomes
Primary outcomes
Driving pressure during the primary T2-T4 window
Driving pressure during the primary T2-T4 window, measured at 5, 10, and 20 minutes after initiation of one-lung ventilation and expressed in cmH2O. In conventional volume-controlled ventilation, driving pressure is calculated as plateau pressure minus applied PEEP. In pressure-regulated volume-targeted/volume-guaranteed modes, driving pressure is calculated as total end-inspiratory pressure minus applied PEEP.
Secondary outcomes
Respiratory system compliance
Respiratory system compliance will be calculated at each applicable time point as tidal volume divided by driving pressure and expressed in mL/cmH2O
Driving pressure at 60 minutes and at the end of one-lung ventilation
Driving pressure will be assessed at 60 minutes after initiation of one-lung ventilation, when this time point is applicable, and at the actual end of one-lung ventilation, to evaluate the persistence of the physiological effect of the assigned PEEP strategy.
Estimated mechanical power during one-lung ventilation
Ventilatory mechanical power will be estimated from prospectively recorded ventilatory parameters using a prespecified calculation method appropriate to the ventilation mode and expressed in J/min.
Incidence of intraoperative hypoxemia during one-lung ventilation
Intraoperative hypoxemia will be defined as SpO2 \<90% sustained for at least 60 seconds during one-lung ventilation with baseline FiO2 0.6, or any episode of SpO2 \<90% requiring immediate clinical intervention at the discretion of the attending anesthesiologist.
Sponsors and contacts
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Jesús Manuel Nieves Alonso
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor institution