BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJesús Manuel Nieves Alonso

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fixed PEEP

    Procedure/Surgery

    Fixed PEEP of 4 cmH2O

  • BMI-adjusted PEEP

    Procedure/Surgery

    BMI-adjusted PEEP calculated as BMI/3 cmH2O

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Fixed PEEP of 4 cmH2OActive comparator 1 intervention
Group B: BMI-adjusted PEEP calculated as BMI/3 cmH2OExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
20 minutes

Secondary outcomes

1

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

Time frame
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
2

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.

Time frame
At 60 minutes after initiation of one-lung ventilation, when applicable, and at the end of one-lung ventilation.
3

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.

Time frame
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
4

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.

Time frame
From initiation until completion of one-lung ventilation during the surgical procedure on Day 1 (up to 1 day).

Other outcomes

Sponsors and contacts

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Jesús Manuel Nieves Alonso

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Sponsor institution