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

Emory University

Status: Completed

Conditions: Dysphagia; Congenital Heart Disease in Children; Vocal Fold Palsy

Treatments: Procedure: Flexible fiberoptic laryngoscopy; Procedure: Laryngeal ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT03882450

IRB00093935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Neonates with congenital cardiac disease (retrospective)

No Intervention group

Description:

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.

Neonates with congenital cardiac disease (prospective)

Active Comparator group

Description:

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.

Treatment:

Procedure: Laryngeal ultrasonography

Procedure: Flexible fiberoptic laryngoscopy