Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in expiratory lung volume as measured by global lung electrical impedance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in expiratory lung volume as measured by global lung electrical impedance
Time Frame: Baseline, 60 mins, 75 mins, 90 mins
Secondary Outcomes
- 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)