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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982639
• Other study ID #: Lung inflammation trial
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery
• Thoracic Diseases

Intervention

Procedure:
• two 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.
• one lung ventilation
In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube

Locations

Country	Name	City	State
Brazil	Hospital Azambuja	Brusque	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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