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Completed

NCT Number: NCT05982639

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.

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Key information

Conditions

Thoracic Diseases Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Azambuja

Brusque, Santa Catarina, 88353-902, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

one lung ventilation

Procedure

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

Primary outcomes

  1. Bronchoalveolar lavage fluid (BALF) levels of IL-6

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure

Secondary outcomes

  1. Bronchoalveolar lavage fluid (BALF) levels of IL-8

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure

  2. Bronchoalveolar lavage fluid (BALF) levels of IL-1

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure

  3. Bronchoalveolar lavage fluid (BALF) levels of TNF

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure

  4. Bronchoalveolar lavage fluid (BALF) levels of oxidative stress

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure

  5. Post-procedure pulmonary complications

    Time frame: Until hospital discharge

    Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung

  6. Systemic levels of inflammatory and oxidative markers

    Time frame: at a maximum 2 hours after the end of the thoracic procedure

    Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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