Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).

Official Title
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Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial

Conditions
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Thoraric Surgery, Surgery Time Expected More Than Two Hours

Intervention / Treatment
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* Procedure: Alveolar recruitment maneuver
* Procedure: PEEP Titration Trial
* Procedure: Lung protective ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned thoracic surgery > 2 hours. Signed informed consent for participation in the study. Exclusion Criteria: Age less than 18 years. Pregnant or breast-feeding. Patients with BMI >35. Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg. Heart failure: NYHA IV. Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support. Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg). Mechanical ventilation in the last 15 days. Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT). Patient with preoperatively CPAP. Participation in another experimental protocol at the time of intervention selection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OLA-iHFNC<br>Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation. | Procedure: Alveolar recruitment maneuver<br>* To start the Alveolar Recruitment Maneuver (ARM) the ventilatory mode will be changed to pressure-controlled mode (PCV) with 20 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 5 cmH2O. The PEEP level will be increased in 5 cmH2O steps every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (20 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)<br>Procedure: PEEP Titration Trial<br>* The ventilation mode will then switch back to volume controlled ventilation with the same baseline settings but with 20 cmH2O PEEP level. Then PEEP will be reduced in 2 cmH2O steps each maintained for 5 breaths the level of PEEP with the best (higher) dynamic compliance.<br>|
| Active Comparator: STD-O2<br>Intraoperatively ventilated patients with a tidal volume of 5-6 ml / kg of ideal body weightand respiratory rate to maintain normal carbon dioxide, PEEP 5 cmH2O. In this group no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, standard oxygen therapy. | Procedure: Lung protective ventilation<br>* Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of postoperative pulmonary complications | composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema. | Up to 7 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of composite of postoperative pulmonary complications | suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome | Up to 30 postoperative days | 
| Reduction of composite of postoperative complications | Renal failure, cardiac failure, sepsis, septic shock, surgical site infection, urinary infection and other pulmonary complications not included in the primary outcome such as leaks, atelectasis, pleural effusion, empyema, dyspnea. | Up to 7 and 30 postoperative days | 
| Intensive care unit and hospital length of stay reduction |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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one lung ventilation, postoperative pulmonary complication, perioperative lung protective ventilation