Surgery, Thoracic Diseases
Conditions
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.
Interventions
PROCEDUREtwo lung ventilation
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.
PROCEDUREone lung ventilation
In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube
Sponsors
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Brazil
Outcome results
None listed