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Electrical Impedence Tomography With ENLIGHT2100

Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05098834
Enrollment
0
Registered
2021-10-28
Start date
2024-08-31
Completion date
2025-01-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation

Keywords

Acute respiratory failure, Breathing tube, Mechanical ventilator

Brief summary

Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed. The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.

Interventions

DEVICEENLIGHT 2100 ventilatory electrical impedance tomograph

The ENLIGHT 2100 system will remain connected to the patient for data acquisition from immediately prior to initiation of the ERT until up to 24 hours following extubation.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients with corrected gestational age less than 37 weeks * Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities) * known pregnancy * Patients previously enrolled in this study will be excluded from participation.

Design outcomes

Primary

MeasureTime frame
Change in expiratory lung volume as measured by global lung electrical impedanceBaseline, 60 mins, 75 mins, 90 mins

Secondary

MeasureTime frame
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedanceBaseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedanceBaseline, 60 mins, 75 mins, 90 mins
Percent of failed extubation as measured by need for re-intubationWithin 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026