Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

Study Overview
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Brief Summary
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This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.

Detailed Description
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One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.

Official Title
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Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?

Conditions
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Ventilator-Induced Lung Injury, Inflammatory Response, Respiratory Complication

Intervention / Treatment
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* Other: Conventional One-Lung Ventilation
* Other: Protective One-lung ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective lobectomy and wedge resection Exclusion Criteria: emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional One-lung ventilation<br>The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight) | Other: Conventional One-Lung Ventilation<br>* Vt 10 ml/kg<br>|
| Experimental: Protective One-Lung Ventilation<br>The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight) | Other: Protective One-lung ventilation<br>* Vt 5 ml/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local cytokine inflammatory response in the two study groups | The levels of cytokines were evaluated in broncho-alveolar lavage (BAL) | Change from Baseline cytokines level and the end of surgery (about 60 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative respiratory in the two study groups | PaO2 /FIO 2 <300 mm Hg and /or the presence of newly developed lung lesions (lung infi ltration and atelectasis) | within 48 hours of the operation | 
| lenght of stay in the two study groups | lenght of hospital stay expressed in days | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery