What side effects are associated with this type of intervention?

Common treatments for extubation, such as mechanical ventilation, sedation, and neuromuscular blockade, have several known side effects. Mechanical ventilation can lead to ventilator-associated pneumonia, barotrauma, and volutrauma. Sedation, often used to keep patients comfortable, can cause prolonged sedation effects, delirium, and respiratory depression. Neuromuscular blockade, used to improve oxygenation and reduce ventilator dyssynchrony, can result in prolonged neuromuscular weakness and increased risk of critical illness polyneuropathy. These side effects need to be carefully managed to ensure successful extubation and recovery.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals or related drugs for the treatment of extubation. However, the Electrical Impedance Tomography (EIT) study focuses on using real-time imaging to assess lung function and predict extubation success. Generally, treatments for extubation readiness involve supportive care, including mechanical ventilation management, and sometimes the use of bronchodilators or corticosteroids to improve lung function. These treatments aim to ensure that the underlying cause of respiratory failure is resolved or significantly improved before extubation.

What other types of research exist?

Promising alternatives to Electrical Impedance Tomography for real-time imaging of air distribution in the lungs for extubation patients include: 1) Magnetic Resonance Imaging (MRI) with ultrashort echo time sequences, which offers high-resolution imaging of lung structure and function without ionizing radiation. 2) Advanced ultrasound techniques, such as point-of-care lung ultrasound, which can provide real-time assessment of lung aeration and pleural conditions. 3) Hyperpolarized gas MRI, which uses inhaled gases like helium-3 or xenon-129 to visualize ventilation distribution and gas exchange in the lungs.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special device to help doctors see how air is distributed in the lungs of children with severe breathing problems. The goal is to determine if these children are ready to have their breathing tubes removed. The device is painless and uses sensors around the chest to create images of the lungs.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met

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.

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,445 Previous Clinical Trials

3,067,769 Total Patients Enrolled

Alexandre Rotta, MD, FCCMPrincipal InvestigatorDuke University

~0 spots leftby Jan 2025

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