Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure (NCT06406725) | Clinical Trial Compass
RecruitingNot Applicable
Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
United States50 participantsStarted 2024-03-30
Plain-language summary
The goal of this prospective, observational study is to evaluate for the presence of vocal fold motion impairment (VFMI) in the children admitted to the pediatric intensive care unit on noninvasive positive pressure ventilation (NIV PPV). Participants will have two ultrasounds of their vocal folds performed, once while on NIV PPV and once after weaned off of the NIV PPV. This results of these scans will be reviewed against one another and against the gold standard, fiberoptic nasolaryngoscopy (FNL). The main question this study aims to answer is: Can POCUS be used to reliably detect VFMI while pediatric patients on supported with NIV PPV?
Who can participate
Age range
1 Day – 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:
* Age 0 to 18 years
* Scheduled to receive a fiberoptic nasolaryngoscopy with the otolaryngology team to assess for vocal fold motion impairment
* Status post great vessel, esophageal, or tracheal surgery that could disrupt the recurrent laryngeal nerve
Exclusion Criteria:
* Tracheostomy in place
* Age \>18 years
* History of vocal cord paralysis/paresis
* Patients who cannot have their neck placed in a neutral or slightly extended position due to injury or ligament laxity
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.
1This trial is looking at detecting vocal fold motion impairment in people on noninvasive positive pressure ventilation — does my specific diagnosis of vocal cord dysfunction or paralysis make me a good candidate to discuss this study with you?
2Since this trial is listed as Phase NA, which usually means it's an observational or diagnostic study rather than a treatment trial, can you explain what would actually happen to me if I participated — would I receive any treatment, or would I mainly be monitored or tested?
3The study is measuring vocal fold motion impairment specifically in the context of noninvasive positive pressure ventilation — am I currently using or likely to need that kind of breathing support, and does that affect whether this trial is relevant to my situation?
4If I took part in this study, could the findings about my vocal fold movement actually benefit my own care, or would the results mainly contribute to research that helps future patients?
5Are there standard diagnostic or treatment options for my vocal cord condition that I should consider first, and how does participating in this detection-focused trial fit alongside those options?
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.