Individualized Perioperative Open Lung Ventilatory Strategy
Not Applicable
Completed
- Conditions
- Abdominal Surgery Expected More Than Two HoursModerated-high Risk of Postoperative Pulmonary Complication
- Interventions
- Procedure: Postoperative CPAPProcedure: Alveolar recruitment maneuverProcedure: Calculation of optimal PEEP
- Registration Number
- NCT02158923
- Lead Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Brief Summary
The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 920
Inclusion Criteria
- Age not less than 18
- Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator).
- Planned abdominal 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Individualized vent. + postop. CPAP Calculation of optimal PEEP Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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 a CPAP of 5 cmH2O (or 10 cmH2O if BMI\> 30) with a FiO2 of 0.5 will be applied. Individualized ventilation Calculation of optimal PEEP Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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. Standard vent. + postoperative CPAP Postoperative CPAP Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, a CPAP of 5 cmH2O (or 10 cmH2O if BMI\> 30) with a FiO2 of 0.5 will be applied. Individualized ventilation Alveolar recruitment maneuver Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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. Individualized vent. + postop. CPAP Alveolar recruitment maneuver Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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 a CPAP of 5 cmH2O (or 10 cmH2O if BMI\> 30) with a FiO2 of 0.5 will be applied. Individualized vent. + postop. CPAP Postoperative CPAP Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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 a CPAP of 5 cmH2O (or 10 cmH2O if BMI\> 30) with a FiO2 of 0.5 will be applied.
- Primary Outcome Measures
Name Time Method Reduction of lung and systemic postoperative complications Up to 7 postoperative days
- Secondary Outcome Measures
Name Time Method Reduction of lung and systemic postoperative complications Up to 30 postoperative days
Trial Locations
- Locations (7)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
🇪🇸Valencia, Spain
Uppsala University Hospital
🇸🇪Uppsala, Uppland, Sweden
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Privado de la Comunidad
🇦🇷Mar de Plata, Buenos Aires, Argentina