Electrical Impedence Tomography With ENLIGHT2100

NCT05098834 | Withdrawn FDA Device

• 1 other identifier: Pro00108931
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation

Keywords

Acute respiratory failure; Breathing tube; Mechanical ventilator

Outcome Measures

Primary Outcomes (1)

• Change in expiratory lung volume as measured by global lung electrical impedance

  Baseline, 60 mins, 75 mins, 90 mins

Secondary Outcomes (3)

• 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

• Percent of failed extubation as measured by need for re-intubation

  Within 24 hours

Study Arms (1)

PICU and PCICU Patients

EXPERIMENTAL

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.

Device: ENLIGHT 2100 ventilatory electrical impedance tomograph

Interventions

ENLIGHT 2100 ventilatory electrical impedance tomograph DEVICE

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.

PICU and PCICU Patients

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Study Officials

• Alexandre Rotta, MD, FCCM

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)