An interventional study of Flexible fiberoptic laryngoscopy and Laryngeal ultrasonography in Vocal Fold Palsy, Dysphagia and Congenital Heart Disease in Children, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Emory University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.
Pediatric vocal fold motion impairment (VFMI) is a well-known cause of dysphonia and dysphagia. Previous studies have demonstrated the most common etiology for pediatric VFMI is cardiothoracic surgery which is possibly due to a variety of mechanisms.The investigators hypothesize that universal screening of neonates for VMFI following congenital cardiac surgery (CCS) will lead to a more accurate incidence and earlier diagnosis of VFMI. They believe that earlier identification will lead to changes in feeding regimens that may decrease length of stay (LOS), decrease time to oral feeding, earlier otolaryngologic intervention if indicated, and decreased rates of readmission for pulmonary or feeding complications. The investigators will also use this information to design a refined algorithm for targeted screening of patients who are more likely to have VFMI based on patient and surgery characteristics.
55 studies on the registry are indexed under Vocal Cord Paralysis; 14 are open to participants now.
This study's enrollment of 94 is above the median of 39 across 38 interventional studies indexed under Vocal Cord Paralysis.
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Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016 will be reviewed. Those who developed VFMI following CCS as diagnosed on flexible fiberoptic laryngoscopy will be identified. Inpatient, outpatient and emergency department (ED) records will be studied for details on postoperative length of stay, time to diagnosis of VFMI, time to initiation of oral feeding, ED visits and readmissions for feeding/weight gain or respiratory issues, and otolaryngology intervention.
Eligible children with known congenital cardiac disease necessitating cardiothoracic surgery will undergo universal screening, i.e., laryngeal ultrasonography and flexible fiberoptic laryngoscopy with examination and video documentation of laryngeal function preoperatively (if they are not intubated and are stable enough to do so) and postoperatively with a 2.4mm flexible laryngoscope and portable ultrasound system while awake.
Procedure: Flexible fiberoptic laryngoscopy · Procedure: Laryngeal ultrasonography
Flexible fiberoptic laryngoscopy with examination and video documentation of laryngeal function preoperatively (if the participant is not intubated and is stable enough to do so) and postoperatively with a 2.4mm flexible laryngoscope will be performed.
Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.
Postoperative length of stay (retrospective)
The number of days of postoperative stay in the hospital will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Time frame: Baseline
Number of readmissions related to feeding difficulty (retrospective)
The number of readmissions to the hospital for feeding difficulties will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Time frame: Baseline
Number of readmissions related to aspiration (retrospective)
The number of readmissions to the hospital for aspiration will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Time frame: Baseline
Time to initiation of feeding therapy (retrospective)
The average time (in days) to start feeding therapy will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Time frame: Baseline
Number of participants with vocal fold motion impairment (prospective)
The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Time frame: Baseline
Postoperative length of stay (prospective)
The number of days of postoperative stay at the hospital will be recorded.
Time frame: Up to 180 days
Time to initiation of feeding therapy (prospective)
The number of days to start feeding therapy will be recorded.
Time frame: Day 7
Number of readmissions related to aspiration (prospective)
The number of readmissions to the hospital for aspiration will be recorded.
Time frame: 3 months, 6 months, 12 months
Number of readmissions related to feeding difficulty (prospective)
The number of readmissions to the hospital for feeding difficulties will be recorded.
Time frame: 3 months, 6 months, 12 months
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Emory University