Electrical Impedance Tomography in One-Lung Ventilation

Ventilator Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728010
• Other study ID #: EITOLV001
• Status: Recruiting
• Start date: December 7, 2018
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: University of Chile
• Contact: Roberto Gonzalez, MD
• Phone: 56999397515
• Email: robgonzalez[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Chile	University of Chile Clinical Hospital	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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