Clinical Trials Logo

Clinical 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). 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?


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06406725
Study type Observational
Source Northwell Health
Contact April Slamowitz, MD
Phone 718-470-3000
Email arslamowitz@gmail.com
Status Recruiting
Phase
Start date March 30, 2024
Completion date May 30, 2026

See also
  Status Clinical Trial Phase
Completed NCT02859974 - Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique N/A
Recruiting NCT05695131 - Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies N/A
Completed NCT01916616 - A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study N/A
Active, not recruiting NCT04593394 - Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma
Active, not recruiting NCT05770518 - Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion N/A
Withdrawn NCT04168671 - CLE During Exercise Testing in Asthma N/A
Completed NCT03046706 - The Role of Vocal Rest After Removal of Benign Lesions From Vocal Cord N/A
Active, not recruiting NCT05246930 - Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma
Withdrawn NCT05114083 - Symptom Scoring for Predicting Vocal Cord Dysfunction (VCD)
Completed NCT04752852 - Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction N/A
Completed NCT04140799 - Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries
Completed NCT02754284 - Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold Phase 1
Completed NCT03356288 - The General Breathing Record Study
Recruiting NCT05686941 - Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study
Completed NCT03501095 - Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy