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Clinical Trials/NCT03882450
NCT03882450
Completed
Not Applicable

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

Emory University1 site in 1 country94 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vocal Fold Palsy
Sponsor
Emory University
Enrollment
94
Locations
1
Primary Endpoint
Postoperative length of stay (retrospective)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
March 13, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nikhila Raol

Assistant Professor

Emory University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperative length of stay (retrospective)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: Baseline

The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.

Time to initiation of feeding therapy (retrospective)

Time Frame: 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)

Time Frame: Up to 180 days

The number of days of postoperative stay at the hospital will be recorded.

Time to initiation of feeding therapy (prospective)

Time Frame: Day 7

The number of days to start feeding therapy will be recorded.

Number of readmissions related to aspiration (prospective)

Time Frame: 3 months, 6 months, 12 months

The number of readmissions to the hospital for aspiration will be recorded.

Study Sites (1)

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