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

April 10, 2020 updated by: Nikhila Raol, Emory University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Neonates with congenital cardiac disease (retrospective)
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.
Active Comparator: Neonates with congenital cardiac disease (prospective)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
Postoperative length of stay (prospective)
Time Frame: Up to 180 days
The number of days of postoperative stay at the hospital will be recorded.
Up to 180 days
Time to initiation of feeding therapy (prospective)
Time Frame: Day 7
The number of days to start feeding therapy will be recorded.
Day 7
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.
3 months, 6 months, 12 months
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.
3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Nikhila Raol, MD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00093935

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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