Electrical Impedance Tomography for Pediatric ARDS

Overseen By Anoopindar Bhalla, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Hemodynamic instability, Pneumothorax, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

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}

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.

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

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

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+

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]

Electrical Impedance Tomography (EIT) is a radiation-free imaging technique that provides real-time monitoring of lung function in pediatric intensive care, allowing for better assessment of conditions like asthma and pleural effusion.

EIT can enhance patient care by offering insights into lung dynamics and the effects of various treatments, which traditional monitoring methods cannot provide, potentially leading to improved outcomes for critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Scenarios of the Application of Electrical Impedance Tomography in Paediatric Intensive Care. Davies, P., Yasin, S., Gates, S., et al.[2021]

Electrical impedance tomography (EIT) showed a strong agreement with computed tomography (CT) in measuring pulmonary perfusion distributions during acute respiratory distress syndrome (ARDS), with a high correlation coefficient of 0.88, indicating that EIT can effectively visualize changes in lung perfusion over time and with different treatments.

While EIT provided similar results to CT in most cases, it tended to underestimate perfusion in the front (ventral) regions and overestimate it in the back (dorsal) regions of the lungs after changing body positions, suggesting that further validation is needed for EIT's accuracy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Tomography Identifies Evolution of Regional Perfusion in a Porcine Model of Acute Respiratory Distress Syndrome. Martin, KT., Xin, Y., Gaulton, TG., et al.[2023]

The use of thoracic electrical impedance tomography (EIT) can effectively guide the adjustment of positive end-expiratory pressure (PEEP) settings in pediatric patients with acute respiratory distress syndrome (pARDS).

This approach allows for real-time assessment of lung compliance and regional tidal volumes, potentially improving mechanical ventilation strategies and outcomes in children with pARDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical ventilation guided by electrical impedance tomography in pediatric acute respiratory distress syndrome. Dmytrowich, J., Holt, T., Schmid, K., et al.[2019]

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 feasible and safe for long-term monitoring of lung function in neonates and young children, with a study involving 200 patients showing minimal adverse effects and a high tolerance for the procedure.

The study revealed that body positioning significantly affects ventilation distribution, with prone positioning enhancing ventilation in the dorsal lung areas, highlighting the importance of patient positioning in respiratory care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Becher, TH., Miedema, M., Kallio, M., et al.[2022]

This study is a large randomized controlled trial involving 376 adult patients with moderate to severe ARDS, aiming to determine if EIT-guided PEEP titration can reduce 28-day mortality compared to standard low FiO2-PEEP table methods.

The trial will assess various clinical outcomes, including ventilator-free days and ICU stay length, to evaluate the effectiveness of individualized PEEP settings based on EIT, potentially minimizing ventilator-induced lung injury.

NCBI (Pubmed)

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. Yuan, X., Zhang, R., Wang, Y., et al.[2023]

Electrical impedance tomography (EIT) can help assess regional ventilation in patients with acute respiratory distress syndrome (ARDS), potentially optimizing mechanical ventilation treatment and reducing the risk of ventilator-associated lung injury (VALI).

The article reviews various studies demonstrating the effectiveness of EIT in different clinical scenarios, highlighting its role in improving patient outcomes during mechanical ventilation for ARDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of regional ventilation in acute respiratory distress syndrome by electrical impedance tomography. Stankiewicz-Rudnicki, M., Gaszyński, T., Gaszyński, W.[2020]

In a study of 18 ARDS patients, electrical impedance tomography (EIT) effectively monitored how positive-end-expiratory pressure (PEEP) titration influenced regional lung ventilation, showing that PEEP can improve gas distribution in the lungs.

The study found that PEEP increased recruitment in dependent lung regions while preventing over-distension in nondependent areas, suggesting that EIT can help tailor PEEP levels to optimize lung function without causing harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive End-expiratory Pressure Titration after Alveolar Recruitment Directed by Electrical Impedance Tomography. Long, Y., Liu, DW., He, HW., et al.[2020]

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]