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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist children with severe lung problems who require breathing machines. Researchers use a tool called Electrical Impedance Tomography (EIT) to determine the optimal machine settings that prevent lung overstretching or collapse. The study compares this method to the standard approach used by doctors. Children who cannot breathe independently and are on breathing machines may be suitable candidates for this trial. As an unphased trial, it provides a unique opportunity for participants to contribute to innovative research that could enhance future care for children with severe lung issues.

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 prior data suggests that this protocol is safe for pediatric ARDS?

Research has shown that Electrical Impedance Tomography (EIT) is safe for monitoring patients, including babies. One study used EIT safely on 200 infants over a long period, indicating that young patients tolerate it well. EIT is non-invasive, meaning it doesn't involve surgery or inserting anything into the body, which generally enhances its safety.

EIT has helped manage breathing support in children with breathing problems, particularly those with acute respiratory distress syndrome (ARDS). This serious condition requires precise adjustments in breathing support, and EIT assists doctors in tailoring care to each child's needs. Overall, evidence suggests that EIT is a safe tool for monitoring lung function in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Electrical Impedance Tomography (EIT) for pediatric acute respiratory distress syndrome (ARDS) because it offers a real-time, non-invasive way to monitor lung function, which is different from traditional methods like chest X-rays or CT scans that expose patients to radiation. Unlike standard treatments that may not provide continuous feedback on lung performance, EIT allows for dynamic adjustments in positive end-expiratory pressure, potentially improving ventilation strategies. This technique could lead to more personalized and effective respiratory support, minimizing lung damage and enhancing recovery in young patients.

What evidence suggests that Electrical Impedance Tomography is effective for pediatric ARDS?

Research has shown that Electrical Impedance Tomography (EIT), which participants in this trial will receive, can guide the use of breathing machines in children with acute respiratory distress syndrome (ARDS). EIT allows doctors to see how air moves in the lungs without radiation. It helps determine the best ventilator settings, which are crucial for assisting breathing. Studies have found that EIT can improve lung function and balance between overdistention and collapse in the lungs. This method enhances patient support by breathing machines. ^{5 6 7 8 9}

Who Is on the Research Team?

Anoopindar Bhalla, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841312/

EIT guided evaluation of regional ventilation distributions in ... The mortality of pediatric acute respiratory distress syndrome (pARDS) is reported as 30% and can be as high as 50% in severe pARDS [1]. The ...

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-018-2195-6

Electrical impedance tomography in acute respiratory distress ... Electrical impedance tomography (EIT) is a monitoring tool that allows one to evaluate at the bedside the distribution of pulmonary ventilation continuously, ...

3. withpower.com withpower.com/trial/phase-respiratory-distress-syndrome-11-2024-5035f

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 ...

4. nature.com nature.com/articles/s41598-019-41774-1

Clinical Scenarios of the Application of Electrical ... EIT is a radiation-free functional modality that enables bedside imaging and monitoring of lung function and expansion.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03112512

A Comparison of Optimal PEEP Determination Guided by ... Positive end-expiratory pressure titration with electrical impedance tomography and pressure-volume curve in severe acute respiratory distress syndrome. Ann ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474599/

Electrical impedance tomography for PEEP titration in ... EIT-guided PEEP titration was associated with a significant reduction in mortality among critically ill patients with ARDS (RR = 0.64, 95% CI: ...

7. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-025-03134-8

EIT guided evaluation of regional ventilation distributions in ... The mortality of pediatric acute respiratory distress syndrome (pARDS) is reported as 30% and can be as high as 50% in severe pARDS [1]. The ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05002478

Infants with Severe Acute Respiratory Distress Syndrome ... Electrical impedance tomography (EIT) and lung ultrasound (LUS) are two non-invasive methods to monitor aeration and lung function parameters.

9. nature.com nature.com/articles/s41390-025-03929-x

Electrical impedance tomography in neonates: a review Becher et al. demonstrated that long-term EIT monitoring is feasible and safe in 200 infants (25 weeks to 36 months post-menstrual age) at risk ...