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

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

Status and phase: Completed; Phase 2

Conditions: Surgery; Thoracic Diseases

Treatments: Procedure: one lung ventilation; Procedure: two lung ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05982639

Lung inflammation trial

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

one-lung ventilation

Other group

Description:

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

Treatment:

Procedure: one lung ventilation

two-lung ventilation and use of pneumothorax with CO2.

Experimental group

Description:

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

Treatment:

Procedure: two lung ventilation