Electrical Impedence Tomography With ENLIGHT2100

June 4, 2024 updated by: Duke University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 13 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICU and PCICU Patients
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in expiratory lung volume as measured by global lung electrical impedance
Time Frame: Baseline, 60 mins, 75 mins, 90 mins
Baseline, 60 mins, 75 mins, 90 mins

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Alexandre Rotta, MD, FCCM, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00108931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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