Back to resultsComparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
Primary Purpose
Thoracic Diseases, Surgery
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
two lung ventilation
one lung ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Thoracic Diseases
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
Sites / Locations
- Hospital AzambujaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
one-lung ventilation
two-lung ventilation and use of pneumothorax with CO2.
Arm Description
Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.
Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Post-procedure pulmonary complications
Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung
Systemic levels of inflammatory and oxidative markers
Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents
Full Information
NCT ID
NCT05982639
First Posted
July 20, 2023
Last Updated
August 5, 2023
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
1. Study Identification
Unique Protocol Identification Number
NCT05982639
Brief Title
Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
Official Title
Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
one-lung ventilation
Arm Type
Other
Arm Description
Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.
Arm Title
two-lung ventilation and use of pneumothorax with CO2.
Arm Type
Experimental
Arm Description
Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax
Intervention Type
Procedure
Intervention Name(s)
two lung ventilation
Intervention Description
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
Intervention Name(s)
one lung ventilation
Intervention Description
In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube
Primary Outcome Measure Information:
Title
Bronchoalveolar lavage fluid (BALF) levels of IL-6
Description
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 Outcome Measure Information:
Title
Bronchoalveolar lavage fluid (BALF) levels of IL-8
Description
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
Title
Bronchoalveolar lavage fluid (BALF) levels of IL-1
Description
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
Title
Bronchoalveolar lavage fluid (BALF) levels of TNF
Description
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
Title
Bronchoalveolar lavage fluid (BALF) levels of oxidative stress
Description
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
Title
Post-procedure pulmonary complications
Description
Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung
Time Frame
Until hospital discharge
Title
Systemic levels of inflammatory and oxidative markers
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe Dal Pizzol, MD, PhD
Phone
+5548991852300
Email
fdpizzol@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Balleter, MD
Organizational Affiliation
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Azambuja
City
Brusque
State/Province
Santa Catarina
ZIP/Postal Code
88353-902
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Jose P Maciel, MD
Phone
+55473396-2200
Email
sac@haccr.org.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
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