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

Not Applicable

• Conditions: Thoraric Surgery; Surgery Time Expected More Than Two Hours
• Interventions: Procedure: Alveolar recruitment maneuver; Procedure: Lung protective ventilation; Procedure: PEEP Titration Trial

• Registration Number: NCT03182062
• 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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Study Start: 2018-09-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03
• Primary Completion: 2020-01
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLA-iHFNC	Alveolar recruitment maneuver	Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (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, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation.
STD-O2	Lung protective ventilation	Intraoperatively ventilated patients with a tidal volume of 5-6 ml / kg of ideal body weightand respiratory rate to maintain normal carbon dioxide, PEEP 5 cmH2O. In this group no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, standard oxygen therapy.
OLA-iHFNC	PEEP Titration Trial	Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (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, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
Intensive care unit and hospital length of stay reduction	1 year

Trial Locations

Locations (4)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital clínico universitario; 🇪🇸 Valencia, Spain