Measuring Lung Pressures in Critically Ill Children Who Are on Mechanical Ventilation (NCT02354365) | Clinical Trial Compass
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Measuring Lung Pressures in Critically Ill Children Who Are on Mechanical Ventilation
United States55 participantsStarted 2014-02
Plain-language summary
Typically doctors adjust the settings on the ventilator to ensure that children receive enough help to decrease the work they perform to breathe, receive enough oxygen through the machine to pass into the blood and to the organs, and remove acid that builds up in the blood. However, sometimes the settings we choose can result in damage to the lungs. We are trying to find a better way to determine the best ventilator settings, which can minimize potential damage to the lungs, and still provide children with enough support to decrease the work they have to do to breathe. We believe we can personalize these choices for each child by looking at the pressure that is generated in the chest while children breathe with the ventilator. This is accomplished by using a small tube which goes through the nose and into the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor pressure. This same tube can then also be used to monitor how much work children need to do to breathe as we are turning down the ventilator in preparation to remove the breathing tube.
Who can participate
Age range
1 Week – 18 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:
We seek to group patients into 3 potential cohorts:
* Normal Lungs (maximum 30 patients): Mechanically ventilated patients without pulmonary parenchymal disease or lower airway disease as measured by flow volume loops consistent with expiratory flow obstruction (e.g. seizures, apnea, upper airway obstruction).
* AHRF (maximum 15 patients): Mechanically ventilated patients with two consecutive Saturation to FiO2 (SF) ratio \< 265 or PaO2 to FiO2 (PF) ratio \< 300 (e.g. pneumonia, ARDS).
* Obstructive airway disease (15 patients): Mechanically ventilated patients with flow volume loops consistent with expiratory flow obstruction (e.g. asthma, bronchiolitis)
Exclusion Criteria:
• Patients with a corrected gestational age of \< 37 weeks or above 18 years of age. Patients with esophageal pathology or inability to utilize an esophageal probe due to anatomy, those on a high frequency oscillator or jet ventilator and those with uncorrected or persistent cyanotic congenital heart diseases will be excluded. Also, patients with an endotracheal tube leak of more than 18% or inability to measure volume, pressure or flow at the endotracheal tube will be excluded from the study
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.