Observational Cohort Study of Distribution of Ventilation in Pediatrics Requiring Mechanical Ventilation by Electrical Impedance Tomography

Completed

Conditions studied: Respiratory Failure, Acute Respiratory Distress Syndrome, Acute Lung Injury

In brief

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. Despite over 40 years since the first pediatric-specific ventilator was designed, there has been no specific cardiopulmonary directed therapy that has proven superior. While mechanical ventilation is generally lifesaving, it can be associated with adverse events. There is evidence building to suggest that adopting a lung protective ventilation strategy by the avoidance of lung over-distension and collapse reduces death. Therefore, timely discovery of these two lung conditions is extremely important in order to mitigate the effects associated with positive pressure mechanical ventilation. The investigators research team has extensive research experience with a non-invasive and radiation free medical device called electrical impendence tomography (EIT). EIT is intended to generate regional information of changes in ventilation. Meaning it can detect this collapse and overdistension. This additional source of information could help fine tune the mechanical ventilator. A baseline of understanding of how often this occurs in the patients the investigators serve is required. Therefore the investigators propose an EIT observation study in their pediatric ICU patient population.

Key facts

Study ID

NCT02247700

Run by

Boston Children's Hospital

People needed

11

Starts

2014-10-01

Expected to finish

2018-11-04

Last updated by the study team

2019-06-04

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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