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

Primary Purpose

Vocal Fold Palsy, Dysphagia, Congenital Heart Disease in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexible fiberoptic laryngoscopy
Laryngeal ultrasonography
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vocal Fold Palsy

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Healthcare of Atlanta

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Neonates with congenital cardiac disease (retrospective)

Neonates with congenital cardiac disease (prospective)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Number of participants with vocal fold motion impairment (prospective)
The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Postoperative length of stay (prospective)
The number of days of postoperative stay at the hospital will be recorded.
Time to initiation of feeding therapy (prospective)
The number of days to start feeding therapy will be recorded.
Number of readmissions related to aspiration (prospective)
The number of readmissions to the hospital for aspiration will be recorded.
Number of readmissions related to feeding difficulty (prospective)
The number of readmissions to the hospital for feeding difficulties will be recorded.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2019
Last Updated
April 10, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03882450
Brief Title
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Official Title
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fold Palsy, Dysphagia, Congenital Heart Disease in Children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neonates with congenital cardiac disease (retrospective)
Arm Type
No Intervention
Arm 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.
Arm Title
Neonates with congenital cardiac disease (prospective)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Flexible fiberoptic laryngoscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laryngeal ultrasonography
Intervention Description
Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.
Primary Outcome Measure Information:
Title
Postoperative length of stay (retrospective)
Description
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.
Time Frame
Baseline
Title
Number of readmissions related to feeding difficulty (retrospective)
Description
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.
Time Frame
Baseline
Title
Number of readmissions related to aspiration (retrospective)
Description
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.
Time Frame
Baseline
Title
Time to initiation of feeding therapy (retrospective)
Description
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.
Time Frame
Baseline
Title
Number of participants with vocal fold motion impairment (prospective)
Description
The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Time Frame
Baseline
Title
Postoperative length of stay (prospective)
Description
The number of days of postoperative stay at the hospital will be recorded.
Time Frame
Up to 180 days
Title
Time to initiation of feeding therapy (prospective)
Description
The number of days to start feeding therapy will be recorded.
Time Frame
Day 7
Title
Number of readmissions related to aspiration (prospective)
Description
The number of readmissions to the hospital for aspiration will be recorded.
Time Frame
3 months, 6 months, 12 months
Title
Number of readmissions related to feeding difficulty (prospective)
Description
The number of readmissions to the hospital for feeding difficulties will be recorded.
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhila Raol, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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

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