Thoraric Surgery, Surgery Time Expected More Than Two Hours
Conditions
Keywords
one lung ventilation, postoperative pulmonary complication, perioperative lung protective ventilation
Brief summary
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).
Interventions
PROCEDUREAlveolar recruitment maneuver
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.)
PROCEDUREPEEP Titration Trial
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.
PROCEDURELung protective ventilation
Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of postoperative pulmonary complications | Up to 7 postoperative days | composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of composite of postoperative pulmonary complications | Up to 30 postoperative days | suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome |
| Reduction of composite of postoperative complications | Up to 7 and 30 postoperative days | 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. |
| Intensive care unit and hospital length of stay reduction | 1 year | — |
Countries
Spain
Contacts
Primary ContactCarlos Ferrando, MD, PhD
Outcome results
None listed