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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 60 mins, 75 mins, 90 mins
Awards & highlights

Study 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.

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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,506 Total Patients Enrolled
Alexandre Rotta, MD, FCCMPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific demographics that are participating in this research project?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical trial, which was first uploaded on October 1st 2022, is actively seeking participants. 40 patients are needed from one location to complete the study."

Answered by AI

Are any further enrollees being accepted into this trial?

"Clinicaltrials.gov confirms that this clinical trial has been open to participants since October 1st 2022 and is still actively recruiting; the listing was last edited on September 8th 2022."

Answered by AI
~27 spots leftby Aug 2024