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

Not Applicable

Completed

• Conditions: Dysphagia; Congenital Heart Disease in Children; Vocal Fold Palsy
• Interventions: Procedure: Flexible fiberoptic laryngoscopy; Procedure: Laryngeal ultrasonography

• Registration Number: NCT03882450
• Lead Sponsor: Emory University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Children 18 and younger with congenital cardiac disease necessitating surgery
• Children 18 and younger whose parents have given and signed an informed consent and HIPAA Authorization as well as the assent of the patient

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Exclusion Criteria

• History of prior cardiac surgery
• Known history of VFMI prior to evaluation
• Children 18 and younger who do not survive the immediate postoperative course will be excluded.
• Further exclusion may be determined at the discretion of the Principal Investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonates with congenital cardiac disease (prospective)	Laryngeal ultrasonography	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.
Neonates with congenital cardiac disease (prospective)	Flexible fiberoptic laryngoscopy	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.

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay (retrospective)	Baseline	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.
Number of readmissions related to feeding difficulty (retrospective)	Baseline	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.
Number of readmissions related to aspiration (retrospective)	Baseline	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.
Number of readmissions related to feeding difficulty (prospective)	3 months, 6 months, 12 months	The number of readmissions to the hospital for feeding difficulties will be recorded.
Number of participants with vocal fold motion impairment (prospective)	Baseline	The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Time to initiation of feeding therapy (retrospective)	Baseline	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.
Postoperative length of stay (prospective)	Up to 180 days	The number of days of postoperative stay at the hospital will be recorded.
Time to initiation of feeding therapy (prospective)	Day 7	The number of days to start feeding therapy will be recorded.
Number of readmissions related to aspiration (prospective)	3 months, 6 months, 12 months	The number of readmissions to the hospital for aspiration will be recorded.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States