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

NCT ID: NCT05982639

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

one-lung ventilation

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

Group Type: OTHER

one lung ventilation

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

two lung ventilation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

one lung ventilation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Felipe Dal Pizzol

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo Balleter, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital Azambuja

Brusque, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

Lung inflammation trial

Identifier Type: -

Identifier Source: org_study_id