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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882450
• Other study ID #: IRB00093935
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Dysphagia
• Heart Diseases
• Vocal Cord Paralysis
• Vocal Fold Palsy

Intervention

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.
• Laryngeal ultrasonography
Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

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