Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorNemours Children's Clinic

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Point-of-Care Ultrasound of the Airway

    Diagnostic test

    Patients 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

50 Participants
are divided into 1 treatment group
Group A: NIV PPV1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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