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Electrical Impedence Tomography With ENLIGHT2100

NCT05098834 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Extubation

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Alexandre Rotta, MD, FCCM · Duke University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098834 on ClinicalTrials.gov