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Electrical Impedance Tomography for Extubation Success in Children

N/A
Waitlist Available
Led By Alexandre Rotta, MD, FCCM
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study
Be younger than 18 years old
Must not have
Patients with corrected gestational age less than 37 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 60 mins, 75 mins, 90 mins
Awards & highlights

Summary

This trial is testing whether using this device can help doctors better predict which children will successfully be able to have the breathing tube removed and avoid any setbacks or complications.

Who is the study for?
This trial is for children under 17 in the Duke Children's PICU or PCICU with acute respiratory failure from lung problems. It excludes those under 37 weeks corrected gestational age, pregnant, previously enrolled, or with conditions that conflict with the ENLIGHT device like pacemakers or severe chest issues.Check my eligibility
What is being tested?
The study tests a new method using the ENLIGHT 2100 to visualize air distribution in lungs during an Extubation Readiness Test (ERT). This could help predict successful removal of breathing tubes in children recovering from respiratory failure.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring with a belt-like device around the chest, side effects are minimal but may include discomfort at the site where the belt is fitted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 17 and have severe lung problems needing intensive care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My baby was born before 37 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 60 mins, 75 mins, 90 mins
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 60 mins, 75 mins, 90 mins for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in expiratory lung volume as measured by global lung electrical impedance
Secondary outcome measures
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance
Percent of failed extubation as measured by need for re-intubation

Trial Design

1Treatment groups
Experimental Treatment
Group I: PICU and PCICU PatientsExperimental Treatment1 Intervention
Patients younger than 17 years of age receiving mechanical ventilation for an acute respiratory illness will be approached to participate prior to initiation of an ERT for clinical purposes.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for extubation focus on ensuring that the patient can maintain adequate ventilation and oxygenation independently. This includes the use of non-invasive ventilation (NIV) to support breathing, bronchodilators to open airways, and corticosteroids to reduce inflammation. Electrical Impedance Tomography (EIT) provides real-time imaging of air distribution in the lungs, which is crucial for monitoring these treatments' effectiveness. EIT helps clinicians assess lung function and detect complications early, ensuring a smoother transition from mechanical ventilation to spontaneous breathing. This real-time feedback is vital for making timely adjustments to treatment plans, thereby improving extubation outcomes.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,446 Total Patients Enrolled
Alexandre Rotta, MD, FCCMPrincipal InvestigatorDuke University
~27 spots leftby Jan 2025