Electrical Impedance Tomography in One-Lung Ventilation

Tidal Volume and PEEP Titration in One-Lung Ventilation With Electrical Impedance Tomography

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Lung
• Intervention / Treatment: 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.

.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Roberto Gonzalez, MD; Phone Number: 56999397515; Email: robgonzalez@uchile.cl

Study Locations

• Chile
  • Santiago, Chile, 562
    • Recruiting
    • University of Chile Clinical Hospital
    • Contact: Roberto A Gonzalez, MD; Phone Number: 56999397515; Email: robgonzalez@uchile.cl
    • Contact: Karen N Venegas, MD; Phone Number: 56977062804; Email: venegaslandaida@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation/ perfusion ratio	Electrical impedance tomography.	1 hour
Pulmonary mechanics	Airway pressure ,esophageal pressure measurement.	1 hour
Arterial gas measurement	5 samples per patient	20 minutes

Collaborators and Investigators

• Sponsor: University of Chile

Publications and helpful links

General Publications

• Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
• Gattinoni L, Protti A, Caironi P, Carlesso E. Ventilator-induced lung injury: the anatomical and physiological framework. Crit Care Med. 2010 Oct;38(10 Suppl):S539-48. doi: 10.1097/CCM.0b013e3181f1fcf7.
• Pinhu L, Whitehead T, Evans T, Griffiths M. Ventilator-associated lung injury. Lancet. 2003 Jan 25;361(9354):332-40. doi: 10.1016/S0140-6736(03)12329-X.
• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
• El Tahan MR, Pasin L, Marczin N, Landoni G. Impact of Low Tidal Volumes During One-Lung Ventilation. A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1767-1773. doi: 10.1053/j.jvca.2017.06.015. Epub 2017 Jun 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: One-lung ventilation; Electrical impedance tomography; Protective ventilation; Ventilator- Induce Lung injury
• Other Study ID Numbers: EITOLV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No