Status:
COMPLETED
Observational Cohort Study of Distribution of Ventilation in Pediatrics Requiring Mechanical Ventilation by Electrical Impedance Tomography
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Draeger Medical, Inc
Conditions:
Respiratory Failure
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
1-17 years
Brief Summary
Respiratory disorders are the leading cause of respiratory failure in children. Thousands of children are admitted to a pediatric intensive care unit each year and placed on mechanical ventilators. De...
Detailed Description
A. Specific Aims/Objectives Specific Aim 1: To determine regional compliance and distribution of ventilation in a cohort of children requiring mechanical ventilation. Hypothesis - Abnormal distributio...
Eligibility Criteria
Inclusion
- All patients who require mechanical ventilatory assistance. This includes invasive and noninvasive ventilation.
- Ages 1 day (full term defined as \> 37 wks GA) to 17 years of age.
Exclusion
- Patients with unstable spinal injuries or diseases
- Body mass index \> 50
- Active implant such as pacemaker, ICD, or diaphragm pacer
- Patient who is having cardiac arrhythmias
- Skin integrity issues in the area that the belt / electrodes will be placed, such as ulcers or open wounds
- Dressings or chest tubes that prohibit the placement of electrodes in the proper plain.
- Open chest
- Flail chest within the regional plain of the belt / electrodes
- If the medical team feels that the patient is not appropriate to enroll in the study based on medical, social or emotional concerns
- If the patient is too unstable to position the belt / electrodes and/or transition to the Draeger ventilator
- Patient has been supported on mechanical ventilation for longer than 48 hours prior to enrollment
- Post-operative spinal fusion patients
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 4 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02247700
Start Date
October 1 2014
End Date
November 4 2018
Last Update
June 4 2019
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115