Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is: • Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure? Participants will be divided in the classic one lung ventilation or two lung ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will be measured after procedures.

Official Title
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Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial

Conditions
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Thoracic Diseases, Surgery

Intervention / Treatment
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* Procedure: two lung ventilation
* Procedure: one lung ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention; Written consent to participate Exclusion Criteria: Pregnant women; Patients on mechanical ventilation prior to the procedure; Patients classified by the American Society of Anesthesiology (ASA) as class 4; Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the two pulmonary technique is superior; Impossibility of using a double-lumen tube or difficult intubation; Patient does not support one-lung ventilation; Patient with previous lung resection surgery

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: one-lung ventilation<br>Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube. | Procedure: one lung ventilation<br>* In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube<br>|
| Experimental: two-lung ventilation and use of pneumothorax with CO2.<br>Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax | Procedure: two lung ventilation<br>* The intervention do not involve a drug or device. It will be compared two different approaches to ventilate the lungs during the procedure . In this arm both lungs will be ventilated inserting a disposable trocar into the pleural cavity, and insufflating CO2 into the thoracic cavity via an insufflator. The insufflation pressure and the flow rate will be set as 8 mmHg and 10 l.min-1, of the cavity with CO2. The insufflator will be adjusted for cavity pressure in 8mmHg and flow of 10L/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoalveolar lavage fluid (BALF) levels of IL-6 | It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure | at a maximum 2 hours after the end of the thoracic procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoalveolar lavage fluid (BALF) levels of IL-8 | It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure | at a maximum 2 hours after the end of the thoracic procedure | 
| Bronchoalveolar lavage fluid (BALF) levels of IL-1 | It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure | at a maximum 2 hours after the end of the thoracic procedure | 
| Bronchoalveolar lavage fluid (BALF) levels of TNF | It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure | at a maximum 2 hours after the end of the thoracic procedure | 
| Bronchoalveolar lavage fluid (BALF) levels of oxidative stress | It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure | at a maximum 2 hours after the end of the thoracic procedure | 
| Post-procedure pulmonary complications | Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung | Until hospital discharge | 
| Systemic levels of inflammatory and oxidative markers | Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents | at a maximum 2 hours after the end of the thoracic procedure |