About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients being seen in our institution's pediatric intensive care unit are the source of potential subjects. This is a 37-bed regional referral center with approximately 2500 admissions annually.
Trial design
Cohort
Prospective
Treatments tested in this trial
Point-of-Care Ultrasound of the Airway
Diagnostic testPatients who are recruited will have an ultrasound performed of their larynx while they are on noninvasive positive pressure ventilation and then a second ultrasound when they are removed from noninvasive positive pressure ventilation. Between the two ultrasounds, the otolaryngology team will perform their fiberoptic nasolaryngoscopy, as per standard unit protocol and patient care.
Treatment groups
Trial outcomes
Primary outcomes
VFMI
Our primary outcome measure will be the detection of vocal fold motion impairment on patients as detected by laryngeal point-of-care ultrasound while on NIV PPV.
Sponsors and contacts
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