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CompletedNCT05982639Updated May 8, 2024

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

A Phase 2 interventional study of two lung ventilation and one lung ventilation in Thoracic Diseases and Surgery, sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Thoracic Diseases
  • Surgery

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03

In context

Thoracic Diseases

68 studies on the registry are indexed under Thoracic Diseases; 14 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 50 interventional studies indexed under Thoracic Diseases.

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Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Other
    one-lung ventilation

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

    Procedure: one lung ventilation

  • 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

Interventions

  • Proceduretwo 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.

  • Procedureone lung ventilation

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

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What researchers measure

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

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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. Post-procedure pulmonary complications

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

    Time frame: Until hospital discharge

  6. Systemic levels of inflammatory and oxidative markers

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

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

07

Study locations

1 site
  • Hospital Azambuja
    Brusque, Santa Catarina 88353-902, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05982639
Lead sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Responsible party
Felipe Dal Pizzol (Professor, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude) — Principal investigator
First posted
Aug 8, 2023
Start date
Jul 20, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
May 8, 2024

Study contacts

Eduardo Balleter, MD
principal investigator · Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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