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

NCT05982639 | Completed Phase 2

• 1 other identifier: Lung inflammation trial
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Diseases; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Bronchoalveolar lavage fluid (BALF) levels of IL-8

  at a maximum 2 hours after the end of the thoracic procedure

• Bronchoalveolar lavage fluid (BALF) levels of IL-1

  at a maximum 2 hours after the end of the thoracic procedure

• Bronchoalveolar lavage fluid (BALF) levels of TNF

  at a maximum 2 hours after the end of the thoracic procedure

• Bronchoalveolar lavage fluid (BALF) levels of oxidative stress

  at a maximum 2 hours after the end of the thoracic procedure

• Post-procedure pulmonary complications

  Until hospital discharge

Study Arms (2)

one-lung ventilation

OTHER

Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.

Procedure: one lung ventilation

two-lung ventilation and use of pneumothorax with CO2.

EXPERIMENTAL

Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax

Procedure: two lung ventilation

Interventions

two lung ventilation PROCEDURE

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.

two-lung ventilation and use of pneumothorax with CO2.

one lung ventilation PROCEDURE

In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube

one-lung ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
• Written consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead

Study Sites (1)

Hospital Azambuja

Brusque, Santa Catarina, 88353-902, Brazil

Location

MeSH Terms

Conditions

Thoracic Diseases

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Eduardo Balleter, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 8, 2023
• Study Start: July 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BR (1)