Protective Ventilation During Pulmonary Lobectomy

Study Overview
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Brief Summary
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The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.

Detailed Description
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The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.

Official Title
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The Effect of Protective Ventilation During Pulmonary Lobectomy

Conditions
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Pulmonary Complication, Thoracic Surgery, Inflammation

Intervention / Treatment
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* Procedure: Convential Ventilation 1
* Procedure: Convential Ventilation 2
* Procedure: Protective Ventilation 1
* Procedure: Protective Ventilation 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.20 Years and older 2.Patients undergoing pulmonary lobectomy Exclusion Criteria: Emergency surgery 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
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Minimum Age: 20 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Convential Ventilation 1<br>Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of 60%. | Procedure: Convential Ventilation 1<br>* High tidal volume, moderate inspired oygen fraction (FiO2).<br>|
| Placebo Comparator: Convential Ventilation 2<br>Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%. | Procedure: Convential Ventilation 2<br>* High tidal volume, high inspired oygen fraction (FiO2).<br>|
| Active Comparator: Protective ventilation 1<br>Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers. | Procedure: Protective Ventilation 1<br>* Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.<br>|
| Active Comparator: Protective ventilation 2<br>Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers. | Procedure: Protective Ventilation 2<br>* Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with pulmonary complication | The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism. | up to postoperative 3days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 /FiO2 |  | 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery | 
| respiratory compliance | Dynamic compliance, Static compliance | 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation | 
| IL6 |  | 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation | 
| IL10 |  | 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation |