NCT03882450

Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vocal Fold Palsy
• Dysphagia
• Congenital Heart Disease in Children

Interventions

Type	Name	Description
PROCEDURE	Flexible fiberoptic laryngoscopy	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.
PROCEDURE	Laryngeal ultrasonography	Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-03-13
• Completion: 2020-03-13
• First posted: 2019-03-20
• Last updated: 2020-04-14

Locations

1 site across 1 country: United States