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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

Tracking Information
First Submitted Date October 9, 2018
First Posted Date November 1, 2018
Last Update Posted Date July 9, 2021
Actual Study Start Date December 7, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2018)
  • Ventilation/ perfusion ratio [ Time Frame: 1 hour ]
    Electrical impedance tomography.
  • Pulmonary mechanics [ Time Frame: 1 hour ]
    Airway pressure ,esophageal pressure measurement.
  • Arterial gas measurement [ Time Frame: 20 minutes ]
    5 samples per patient
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electrical Impedance Tomography in One-Lung Ventilation
Official Title Tidal Volume and PEEP Titration in One-Lung Ventilation With Electrical Impedance Tomography
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ventilator Lung
Intervention 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.
Study Groups/Cohorts One-Lung Ventilarion
Thoracic surgery cases with one-lung ventilation strategy.
Intervention: Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 30, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Roberto Gonzalez, MD 56999397515 robgonzalez@uchile.cl
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728010
Other Study ID Numbers EITOLV001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Roberto Gonzalez Cornejo, University of Chile
Study Sponsor University of Chile
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Chile
Verification Date January 2021