Vocal Cord DysfunctionNCT06406725
Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
An observational study of Vocal Cord Dysfunction and Vocal Cord Paralysis, run by Nemours Children's Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Dysfunction, Vocal Cord Paralysis, Vocal Cord Paresis
- What is being tested?
- Point-of-Care Ultrasound of the Airway
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2024to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cohen Children's Medical Center
Queens, New York, 11040
April Slamowitz, MD, 718-470-3000, aslamowitz@northwell.edu
Catherine Geller, MD, 718-470-3000, cgeller@northwell.edu
About this study
Official title: Point-of-Care Ultrasound to Detect Vocal Fold Motion Impairment on Pediatric Patients on Noninvasive Positive Pressure Ventilation
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?
Read the detailed description
Vocal fold motion impairment (VFMI) is a known sequela of airway, esophageal, and great vessel surgery, due to direct damage of the recurrent laryngeal nerve(s). VFMI can be diagnosed with the gold standard approach, direct visualization using fiberoptic nasolaryngoscopy (FNL).
Paralysis of the vocal folds leads to glottic incompetence, which can cause dysphonia, feeding and swallowing difficulties, risk of aspiration, and airway compromise. Taken together, these symptoms can then lead to poor weight gain, chronic aspiration, need for hospitalization, recurrent pneumonias, and needs for alternative routes of nutrition.
The presence of VFMI after cardiovascular surgeries occurs anywhere from 8.8% to 58.7%, depending on the procedure performed and institution. Nerve injury may recover spontaneously, however the extent and timing are variable.
Although FNL has been historically thought to be a safe procedure, recent literature and case reports have noted that FNL is potentially noxious to the pediatric patient. This noxious stimuli can lead to tachycardia, tachypnea, oxygen desaturation, epistaxis, vasovagal events, laryngospasm, and aspiration events. In pediatric patients who have undergone cardiovascular surgery, the noxious stimuli from FNL can be potentially life-threatening. Specifically for those with single ventricle physiology and pulmonary hypertension, the noxious FNL can lead to a rapid increase in pulmonary vascular resistance, which can cause the pulmonary arterial pressure to exceed that of the systemic vascular pressure. This could then lead to an acute decrease in the right ventricular ejection fraction, right heart failure, and even sudden death.
Recently, laryngeal ultrasound (LUS) has been proposed as a safer, non-invasive modality to help screen patients who are at risk of VFMI. It has high sensitivity and specificity for VFMI and is simple to before by radiology technicians or bedside providers in the pediatric intensive care unit with POCUS.
This study aims to answer the question: Can POCUS be used to reliably detect VFMI while pediatric patients on supported with NIV PPV? We predict that LUS will have high sensitivity and specificity to detect VFMI, despite the addition of NIV PPV.
- Conditions
- Vocal Cord Dysfunction, Vocal Cord Paralysis, Vocal Cord Paresis, Recurrent Laryngeal Nerve Palsy, Recurrent Laryngeal Nerve Injuries
- Being tested
- Point-of-Care Ultrasound of the Airway
- Medical subject headings
- Vocal Cord Dysfunction, Vocal Cord Paralysis, Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care Ultrasound of the AirwayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| NIV PPV | We will recruit patients who are currently on noninvasive positive pressure ventilation (NIV PPV) who are scheduled for fiberoptic nasolaryngoscopy (FNL) with the otolaryngology team for evaluation of vocal fold motion impairment (VFMI). Receives: Diagnostic Test: Point-of-Care Ultrasound of the Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start30 Mar 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Slamowitz, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406725
- Sponsor's protocol ID
- 23-0649_A
- Status last verified
- Apr 2026
- First submitted
- 6 May 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ongkasuwan J, Ocampo E, Tran B. Laryngeal ultrasound and vocal fold movement in the pediatric cardiovascular intensive care unit. Laryngoscope. 2017 Jan;127(1):167-172. doi: 10.1002/lary.26051. Epub 2016 Apr 23.
PubMed 27107409Marvin K, Coulter M, Johnson C, Friesen T, Morris K, Brigger MT. Dysphagia Outcomes Following Surgical Management of Unilateral Vocal Fold Immobility in Children: A Systematic Review. Otolaryngol Head Neck Surg. 2023 Apr;168(4):602-610. doi: 10.1177/01945998221084891. Epub 2023 Feb 5.
PubMed 35290106Izadi S, Zendejas B, Meisner J, Kamran A, Mohammed S, Demehri F, Staffa S, Zurakowski D, Hseu A, Cunningham M, Choi S, Barnewolt C. Diagnostic Accuracy of Laryngeal Ultrasound for Evaluating Vocal Fold Movement Impairment in Children. J Pediatr Surg. 2024 Jan;59(1):109-116. doi: 10.1016/j.jpedsurg.2023.09.017. Epub 2023 Sep 22.
PubMed 37845124
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasound to Detect Vocal Fold Motion Impairment on Pediatric Patients on Noninvasive Positive Pressure Ventilation
- ClinicalTrials.gov ID
- NCT06406725
- Acronym / sponsor ID
- 23-0649_A
- Conditions
- Vocal Cord Dysfunction, Vocal Cord Paralysis, Vocal Cord Paresis, Recurrent Laryngeal Nerve Palsy, Recurrent Laryngeal Nerve Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Vocal fold motion impairment (VFMI) is a known sequela of airway, esophageal, and great vessel surgery, due to direct damage of the recurrent laryngeal nerve(s). VFMI can be diagnosed with the gold standard approach, direct visualization using fiberoptic nasolaryngoscopy (FNL).
Paralysis of the vocal folds leads to glottic incompetence, which can cause dysphonia, feeding and swallowing difficulties, risk of aspiration, and airway compromise. Taken together, these symptoms can then lead to poor weight gain, chronic aspiration, need for hospitalization, recurrent pneumonias, and needs for alternative routes of nutrition.
The presence of VFMI after cardiovascular surgeries occurs anywhere from 8.8% to 58.7%, depending on the procedure performed and institution. Nerve injury may recover spontaneously, however the extent and timing are variable.
Although FNL has been historically thought to be a safe procedure, recent literature and case reports have noted that FNL is potentially noxious to the pediatric patient. This noxious stimuli can lead to tachycardia, tachypnea, oxygen desaturation, epistaxis, vasovagal events, laryngospasm, and aspiration events. In pediatric patients who have undergone cardiovascular surgery, the noxious stimuli from FNL can be potentially life-threatening. Specifically for those with single ventricle physiology and pulmonary hypertension, the noxious FNL can lead to a rapid increase in pulmonary vascular resistance, which can cause the pulmonary arterial pressure to exceed that of the systemic vascular pressure. This could then lead to an acute decrease in the right ventricular ejection fraction, right heart failure, and even sudden death.
Recently, laryngeal ultrasound (LUS) has been proposed as a safer, non-invasive modality to help screen patients who are at risk of VFMI. It has high sensitivity and specificity for VFMI and is simple to before by radiology technicians or bedside providers in the pediatric intensive care unit with POCUS.
This study aims to answer the question: Can POCUS be used to reliably detect VFMI while pediatric patients on supported with NIV PPV? We predict that LUS will have high sensitivity and specificity to detect VFMI, despite the addition of NIV PPV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIV PPV | – | Diagnostic Test: Point-of-Care Ultrasound of the AirwayWe will recruit patients who are currently on noninvasive positive pressure ventilation (NIV PPV) who are scheduled for fiberoptic nasolaryngoscopy (FNL) with the otolaryngology team for evaluation of vocal fold motion impairment (VFMI). |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care Ultrasound of the AirwayPatients 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. | Diagnostic test | NIV PPV |
Primary outcome
VFMI
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 27107409Ongkasuwan J, Ocampo E, Tran B. Laryngeal ultrasound and vocal fold movement in the pediatric cardiovascular intensive care unit. Laryngoscope. 2017 Jan;127(1):167-172. doi: 10.1002/lary.26051. Epub 2016 Apr 23.
- Background: PubMed 35290106Marvin K, Coulter M, Johnson C, Friesen T, Morris K, Brigger MT. Dysphagia Outcomes Following Surgical Management of Unilateral Vocal Fold Immobility in Children: A Systematic Review. Otolaryngol Head Neck Surg. 2023 Apr;168(4):602-610. doi: 10.1177/01945998221084891. Epub 2023 Feb 5.
- Background: PubMed 37845124Izadi S, Zendejas B, Meisner J, Kamran A, Mohammed S, Demehri F, Staffa S, Zurakowski D, Hseu A, Cunningham M, Choi S, Barnewolt C. Diagnostic Accuracy of Laryngeal Ultrasound for Evaluating Vocal Fold Movement Impairment in Children. J Pediatr Surg. 2024 Jan;59(1):109-116. doi: 10.1016/j.jpedsurg.2023.09.017. Epub 2023 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Cord Dysfunction and Vocal Cord Paralysis, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact April Slamowitz, MD (718-470-3000, arslamowitz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VFMI (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406725, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.