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

N/AUnknownNCT03182062

Fundación para la Investigación del Hospital Clínico de Valencia1,400 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,400

Conditions

Thoraric Surgery Surgery Time Expected More Than Two Hours

Interventions

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.)

PEEP Titration TrialPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital clínico universitario

Valencia, Spain

RECRUITING

Outcomes

Primary Outcomes

Reduction of postoperative pulmonary complications

composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.

Time frame: Up to 7 postoperative days

Secondary Outcomes

Reduction of composite of postoperative pulmonary complications

suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome

Time frame: 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.

Time frame: Up to 7 and 30 postoperative days

Intensive care unit and hospital length of stay reduction

Time frame: 1 year

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts