Electrical Impedence Tomography With ENLIGHT2100

Extubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05098834
• Other study ID #: Pro00108931
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Melissa Harward
• Phone: 919-668-3910
• Email: melissa.harward[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extubation

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in expiratory lung volume as measured by global lung electrical impedance		Baseline, 60 mins, 75 mins, 90 mins
Secondary	Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance		Baseline, 60 mins, 75 mins, 90 mins
Secondary	Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance		Baseline, 60 mins, 75 mins, 90 mins
Secondary	Percent of failed extubation as measured by need for re-intubation		Within 24 hours