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Electrical Impedance Tomography in One-Lung Ventilation

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ClinicalTrials.gov Identifier: NCT03728010
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Roberto Gonzalez Cornejo, University of Chile

Brief Summary:

Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called "protective ventilation".

Although ventilation with protective parameters seems to reduce VILI in one-lung ventilation, the optimal parameters are not clear.


Condition or disease Intervention/treatment
Ventilator Lung Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement

Detailed Description:

This research aims to describe the ventilation, perfusion and pulmonary mechanics on one-lung ventilation with different levels of tidal volume and PEEP.

An extreme situation of VILI occurs in thoracic surgery, where the atelectasis of a lung is required, ventilating throughout the surgery only the contralateral one. This generates an inflammatory state, with the release of alveolar cytokines from both the non-ventilated and ventilated lungs, which potentiates the development of damage in the lung parenchyma. In addition, one lung ventilation has traditionally been performed with high tidal volume (Vt) values and low PEEP. In this context, the development of VILI is even more probable, so extreme measures of protection in this kind of ventilation are necessary.

The electrical impedance tomography will allow the investigators to obtain a visual and quantitative representation of the areas of ventilation and perfusion of the lung. By relating the tidal volume and PEEP with the tomographic results, it is expected to define mechanical ventilation parameters that achieve the best ventilation/perfusion ratio for patients in one-lung ventilation. Specifically, analyze the distribution and deformation of the ventilated areas in the different lung regions and its correlation with respiratory mechanics and volumetric capnography. This will allow the investigators to make a better definition of the tidal volume and PEEP in patients undergoing one-lung ventilation.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tidal Volume and PEEP Titration in One-Lung Ventilation With Electrical Impedance Tomography
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
One-Lung Ventilarion
Thoracic surgery cases with one-lung ventilation strategy.
Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement
After general anesthesia, patients will be ventilated with three tidal volume level (4, 6 and 8 cc / Kg / IBW), in two levels of PEEP, 6 cm2 H20, and best PEEP, the latter obtained after a recruitment maneuver and decremental titration.




Primary Outcome Measures :
  1. Ventilation/ perfusion ratio [ Time Frame: 1 hour ]
    Electrical impedance tomography.

  2. Pulmonary mechanics [ Time Frame: 1 hour ]
    Airway pressure ,esophageal pressure measurement.

  3. Arterial gas measurement [ Time Frame: 20 minutes ]
    5 samples per patient



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients between 18 and 75 years old. With pulmonary diseases that require thoracic surgery with one-lung ventilation.
Criteria

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) classification I-III
  • Age 18-75 Years
  • Elective thoracic surgery
  • One-Lung Ventilation
  • Healthy non ventilated lung

Exclusion Criteria:

  • ASA classification > III
  • BMI (Body mass index) > 30
  • Emergency surgery
  • Pregnancy
  • Patients includes in other protocols

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728010


Contacts
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Contact: Roberto Gonzalez, MD 56999397515 robgonzalez@uchile.cl

Locations
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Chile
University of Chile Clinical Hospital Recruiting
Santiago, Chile, 562
Contact: Roberto A Gonzalez, MD    56999397515    robgonzalez@uchile.cl   
Contact: Karen N Venegas, MD    56977062804    venegaslandaida@gmail.com   
Sponsors and Collaborators
University of Chile
Publications:
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Responsible Party: Roberto Gonzalez Cornejo, Anesthesiologist, University of Chile
ClinicalTrials.gov Identifier: NCT03728010    
Other Study ID Numbers: EITOLV001
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Gonzalez Cornejo, University of Chile:
Electrical impedance tomography
One-lung ventilation
Protective ventilation
Ventilator- Induce Lung injury