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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Thoracic Diseases
• Intervention / Treatment: Procedure: one lung ventilation; Procedure: two lung ventilation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Brusque, Santa Catarina, Brazil, 88353-902
      • Hospital Azambuja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: one-lung ventilation; Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.	Procedure: one lung ventilation; In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube
Experimental: two-lung ventilation and use of pneumothorax with CO2.; Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Investigators: Principal Investigator: Eduardo Balleter, MD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 5, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: Lung inflammation trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No