Electrical Impedance Tomography for Pediatric ARDS

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Hemodynamic instability, Pneumothorax, ECMO, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows: Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations. Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP. Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Electrical Impedance Tomography for Pediatric ARDS?

Research shows that Electrical Impedance Tomography (EIT) helps guide mechanical ventilation in children with acute respiratory distress syndrome by optimizing lung recruitment and minimizing overdistension. EIT provides real-time imaging of lung function, which can improve patient outcomes by allowing personalized adjustments to ventilator settings. ^{1 2 3 4 5}

Is Electrical Impedance Tomography (EIT) safe for use in children?

EIT is generally safe for use in children, with studies showing it is well tolerated and only minor skin irritations like temporary redness occurring in about 10% of patients. No moderate or severe adverse events were reported in studies involving prolonged monitoring in neonates and young children. ^{6 7 8 9 10}

How is Electrical Impedance Tomography different from other treatments for pediatric ARDS?

Electrical Impedance Tomography (EIT) is unique because it provides real-time, bedside imaging of lung function without using radiation, allowing doctors to monitor and adjust ventilation settings to improve lung function in children with ARDS. This noninvasive technique helps optimize breathing support by showing how air is distributed in the lungs, which is not possible with other standard treatments. ^{1 2 3 6 11}

Research Team

Anoopindar Bhalla, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for children under 18 years old who are on mechanical ventilation and not breathing on their own, meeting the criteria for Pediatric Acute Respiratory Distress Syndrome (PARDS).

Inclusion Criteria

Meets PARDS criteria

I am under 18 years old.

Is on invasive mechanical ventilation

Exclusion Criteria

Patients with uncuffed endotracheal or tracheostomy tubes

I cannot have treatments that increase carbon dioxide in my blood.

Non-conventional ventilation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo PEEP titration protocol with EIT monitoring to identify optimal PEEP levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Electrical Impedance Tomography (Device)

Trial Overview The study tests a method called Electrical Impedance Tomography (EIT) to find the best Positive End-Expiratory Pressure (PEEP) in ventilated children with lung issues. It compares EIT's recommended PEEP with current guidelines.

Participant Groups

Group I: Electrical Impedance Tomography positive end-expiratory pressure Experimental Treatment 1 Intervention

Patients will be monitored using Electrical Impedance Tomography and the positive end-expiratory pressure titration tool as their positive end-expiratory pressure is adjusted according to a step wise positive end-expiratory pressure titration protocol.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Paul S. Viviano

Children's Hospital Los Angeles

Chief Executive Officer since 2015

Master of Public Health from UCLA Fielding School of Public Health

Alan S. Wayne

Children's Hospital Los Angeles

Chief Medical Officer since 2023

MD

Findings from Research

In a study of 12 children with moderate-to-severe pediatric acute respiratory distress syndrome (pARDS), the positive end-expiratory pressure (PEEP) levels determined by chest electrical impedance tomography (EIT) were found to be similar to those determined by global dynamic respiratory system compliance (Crs), with differences of only ± 2 cm H2O in most cases.

The study suggests that using PEEP selected based on the best Crs may be just as effective as EIT-guided methods for managing ventilation in pARDS, although further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Global and Regional Compliance-Guided Positive End-Expiratory Pressure Titration on Regional Lung Ventilation in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. Ren, H., Xie, L., Wang, Z., et al.[2022]

In a study involving 8 children with early acute respiratory distress syndrome, personalized mechanical ventilation using electrical impedance tomography successfully reduced lung collapse by an average of 9.1% without significantly increasing lung overdistension.

The protocol improved global respiratory system compliance and gas exchange, indicating that this targeted approach to adjusting positive end-expiratory pressure can enhance respiratory function in critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Ventilation Guided by Electrical Impedance Tomography in Children With Acute Lung Injury. Rosemeier, I., Reiter, K., Obermeier, V., et al.[2022]

In a study involving 25 critically ill children, electrical impedance tomography (EIT) effectively showed that children with worse oxygen impairment or those on controlled ventilation modes had a more ventral distribution of ventilation, indicating its potential to guide ventilation strategies.

The application of EIT was found to be safe, with no adverse events reported during its use, suggesting it can be a reliable tool for monitoring lung function in pediatric ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of Ventilation Measured by Electrical Impedance Tomography in Critically Ill Children. Inany, HS., Rettig, JS., Smallwood, CD., et al.[2021]

Electrical impedance tomography (EIT) is a promising imaging technique that can enhance the management of acute respiratory distress syndrome (ARDS) by monitoring responses to various interventions, such as prone positioning and mechanical ventilation adjustments.

While EIT has shown effectiveness in improving physiological parameters and detecting complications like pneumothorax, its impact on actual clinical outcomes in ARDS patients still needs further investigation through clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. Jimenez, JV., Weirauch, AJ., Culter, CA., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Global and Regional Compliance-Guided Positive End-Expiratory Pressure Titration on Regional Lung Ventilation in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanical Ventilation Guided by Electrical Impedance Tomography in Children With Acute Lung Injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Clinical Scenarios of the Application of Electrical Impedance Tomography in Paediatric Intensive Care. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Tomography Identifies Evolution of Regional Perfusion in a Porcine Model of Acute Respiratory Distress Syndrome. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mechanical ventilation guided by electrical impedance tomography in pediatric acute respiratory distress syndrome. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Distribution of Ventilation Measured by Electrical Impedance Tomography in Critically Ill Children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial. [2023]

9. Poland pubmed.ncbi.nlm.nih.gov

Assessment of regional ventilation in acute respiratory distress syndrome by electrical impedance tomography. [2020]

10. China pubmed.ncbi.nlm.nih.gov

Positive End-expiratory Pressure Titration after Alveolar Recruitment Directed by Electrical Impedance Tomography. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. [2023]