Individualized Perioperative Open Lung Ventilatory Strategy

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.

Conditions
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Moderated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two Hours

Intervention / Treatment
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* Procedure: Alveolar recruitment maneuver
* Procedure: Calculation of optimal PEEP
* Procedure: Postoperative CPAP


Participation Criteria
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Eligibility Criteria
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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.

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized ventilation<br>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. | Procedure: Alveolar recruitment maneuver<br>* To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)<br>Procedure: Calculation of optimal PEEP<br>* Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .<br>|
| Experimental: Individualized vent. + postop. CPAP<br>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. | Procedure: Alveolar recruitment maneuver<br>* To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)<br>Procedure: Calculation of optimal PEEP<br>* Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .<br>Procedure: Postoperative CPAP<br>* Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.<br>|
| No Intervention: Standard ventilation<br>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. | |
| Active Comparator: Standard vent. + postoperative CPAP<br>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. | Procedure: Postoperative CPAP<br>* Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of lung and systemic postoperative complications |  | Up to 7 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of lung and systemic postoperative complications |  | Up to 30 postoperative days | 

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