Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
- Conditions
- Thoracic DiseasesSurgery
- Interventions
- Procedure: two lung ventilationProcedure: one lung ventilation
- Registration Number
- NCT05982639
- Lead Sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
- Written consent to participate
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description two-lung ventilation and use of pneumothorax with CO2. two lung ventilation Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax one-lung ventilation one lung ventilation Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.
- Primary Outcome Measures
Name Time Method Bronchoalveolar lavage fluid (BALF) levels of IL-6 at a maximum 2 hours after the end of the thoracic procedure It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure
- Secondary Outcome Measures
Name Time Method Bronchoalveolar lavage fluid (BALF) levels of TNF at a maximum 2 hours after the end of the thoracic procedure It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of IL-8 at a maximum 2 hours after the end of the thoracic procedure It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of IL-1 at a maximum 2 hours after the end of the thoracic procedure It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure
Systemic levels of inflammatory and oxidative markers at a maximum 2 hours after the end of the thoracic procedure Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents
Bronchoalveolar lavage fluid (BALF) levels of oxidative stress at a maximum 2 hours after the end of the thoracic procedure It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure
Post-procedure pulmonary complications Until hospital discharge Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung
Trial Locations
- Locations (1)
Hospital Azambuja
🇧🇷Brusque, Santa Catarina, Brazil