Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06494215

Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode

Led by University of Sao Paulo General Hospital · Updated on 2024-07-10

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the Pendelluft phenomenon, a cause of lung damage in patients who are mechanically ventilated and breathing on their own. The study focuses on comparing different methods to measure the stress Pendelluft causes on lung tissue, using electrical impedance tomography. It explores how regional lung volume and local pressure contribute to lung overstress during invasive ventilation in pressure support mode. Patients will undergo variations in pressure support levels during invasive mechanical ventilation. They will be monitored first at their usual clinical pressure support for about 30 minutes, then at 50% lower and 50% higher pressure support levels in a randomly assigned order. During each phase, blood gas samples will be collected, and specific inspiratory and expiratory pauses will be performed to record pressures and estimate lung mechanics. The collected data will be analyzed later to compare different Pendelluft measurement methods. Participants will have respiratory mechanics monitored through electrical impedance tomography and esophageal/gastric pressure measurements. The study involves recording lung function and collecting blood samples at each pressure level, with pauses to capture plateau pressures. Researchers will measure Pendelluft magnitude and respiratory effort during these periods. The protocol includes safety monitoring, and ventilator settings will be returned to baseline after testing. Total participation time includes multiple 30-minute monitoring sessions under different pressure supports.

CONDITIONS

Brief Title

Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Sedation or neuromuscular blockade
  • Absence of respiratory effort
  • Contraindications to esophageal balloon catheter positioning or electrical impedance tomography belt positioning
  • Presence of pneumothorax or active air leaks
  • Hemodynamic instability
  • Absence of informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 3 hours on the study day

Participants undergo monitoring of respiratory mechanics and regional ventilation using electrical impedance tomography and placement of an esophageal/gastric balloon catheter. Blood gas samples and inspiratory and expiratory pauses are performed to collect data at clinical pressure support and at varied pressure support levels.

1 in-person visit with continuous monitoring and multiple measurements during the visit

Trial Site Locations

Total: 1 location

1

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil, 05403-900

Actively Recruiting

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Research Team

M

Marcelo BP Amato, MD PhD

E

Emily Sofia Ceron

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury.

Takeshi Yoshida, Akinori Uchiyama, Nariaki Matsuura...

https://pubmed.ncbi.nlm.nih.gov/22430241

Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management.

Takeshi Yoshida, Yuji Fujino, Marcelo B P Amato...

https://pubmed.ncbi.nlm.nih.gov/27786562

Pendelluft in hypoxemic patients resuming spontaneous breathing: proportional modes versus pressure support ventilation.

Daniel H Arellano, Roberto Brito, Caio C A Morais...

https://pubmed.ncbi.nlm.nih.gov/38117367

Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study.

Giacomo Bellani, Giacomo Grasselli, Maddalena Teggia-Droghi...

https://pubmed.ncbi.nlm.nih.gov/27160458

Inflammatory biomarkers and pendelluft magnitude in ards patients transitioning from controlled to partial support ventilation.

Rodrigo A Cornejo, Daniel H Arellano, Pablo Ruiz-Rudolph...

https://pubmed.ncbi.nlm.nih.gov/36418386

Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group.

Inéz Frerichs, Marcelo B P Amato, Anton H van Kaam...

https://pubmed.ncbi.nlm.nih.gov/27596161