Electrical Impedence Tomography With ENLIGHT2100

Not Applicable

Not yet recruiting

• Conditions: Extubation
• Interventions: Device: ENLIGHT 2100 ventilatory electrical impedance tomograph

• Registration Number: NCT05098834
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Study Start: 2024-08
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PICU and PCICU Patients	ENLIGHT 2100 ventilatory electrical impedance tomograph	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.

Primary Outcome Measures

Name	Time	Method
Change in expiratory lung volume as measured by global lung electrical impedance	Baseline, 60 mins, 75 mins, 90 mins

Secondary Outcome Measures

Name	Time	Method
Percent of failed extubation as measured by need for re-intubation	Within 24 hours
Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance	Baseline, 60 mins, 75 mins, 90 mins
Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance	Baseline, 60 mins, 75 mins, 90 mins

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States