Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation (iPROVE-OLV)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Unknown

Conditions: Thoraric Surgery; Surgery Time Expected More Than Two Hours

Treatments: Procedure: PEEP Titration Trial; Procedure: Lung protective ventilation; Procedure: Alveolar recruitment maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT03182062

iPROVE-OLV

Details and patient eligibility

About

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).

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,400 participants in 2 patient groups

OLA-iHFNC

Active Comparator group

Description:

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.

Treatment:

Procedure: PEEP Titration Trial

Procedure: Alveolar recruitment maneuver

STD-O2

Active Comparator group

Description:

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.

Treatment:

Procedure: Lung protective ventilation