An interventional study of ENLIGHT 2100 ventilatory electrical impedance tomograph in Extubation, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: ENLIGHT 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.
Change in expiratory lung volume as measured by global lung electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance
Time frame: Baseline, 60 mins, 75 mins, 90 mins
Percent of failed extubation as measured by need for re-intubation
Time frame: Within 24 hours
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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