Observational Cohort Study of Distribution of Ventilation in Pediatrics Requiring Mechanical Vent… (NCT02247700) | Clinical Trial Compass
CompletedNot Applicable
Observational Cohort Study of Distribution of Ventilation in Pediatrics Requiring Mechanical Ventilation by Electrical Impedance Tomography
United States11 participantsStarted 2014-10-01
Plain-language 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. 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.
Who can participate
Age range
1 Day – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.