The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.

Official Title
-----------------
The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation

Conditions
-----------------
Mechanical Ventilation Complication, Thoracic Surgery, Inflammation

Intervention / Treatment
-----------------
* Procedure: protective ventilation
* Procedure: Recruitment maneuver combined with protective ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 Years and older Patients undergoing thoracic surgery Exclusion Criteria: Emergency surgery Heart failure Pulmonary hypertension Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values Coagulation disorder Pulmonary or extrapulmonary infections History of treatment with steroid in 3 months before surgery History of recurrent pneumothorax History of lung resection surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional<br>Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP | |
| Active Comparator: Protective<br>Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. | Procedure: protective ventilation<br>* low tidal volume and PEEP<br>|
| Active Comparator: Recruitment<br>Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation. | Procedure: Recruitment maneuver combined with protective ventilation<br>* Low tidal volume, PEEP and recruitment maneuver<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of IL-8, TNFa in the bronchoalveolar lavage |  | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage |  | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | 
| plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa |  | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | 
| oxygenation | Changes in PaO2/FIO2 ratio | 1 hour after extubation | 
| Chest-X ray |  | 7 days after surgery |