Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoraric Surgery
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Enrollment
- 1400
- Locations
- 4
- Primary Endpoint
- Reduction of postoperative pulmonary complications
- Last Updated
- 7 years ago
Overview
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).
Investigators
Carlos Ferrando
Principal Investigador
Fundación para la Investigación del Hospital Clínico de Valencia
Eligibility Criteria
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 \>
- •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.
Outcomes
Primary Outcomes
Reduction of postoperative pulmonary complications
Time Frame: Up to 7 postoperative days
composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.
Secondary Outcomes
- Reduction of composite of postoperative complications(Up to 7 and 30 postoperative days)
- Reduction of composite of postoperative pulmonary complications(Up to 30 postoperative days)
- Intensive care unit and hospital length of stay reduction(1 year)