Electrical Impedence Tomography With ENLIGHT2100

Duke University

Status: Withdrawn

Conditions: Extubation

Treatments: Device: ENLIGHT 2100 ventilatory electrical impedance tomograph

Study type: Interventional

Funder types: Other

Identifiers

NCT05098834

Pro00108931

Details and patient eligibility

About

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.

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PICU and PCICU Patients

Experimental group

Description:

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.

Treatment:

Device: ENLIGHT 2100 ventilatory electrical impedance tomograph