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Completed

NCT Number: NCT03882450

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

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.

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Key information

Conditions

Vocal Fold Palsy Congenital Heart Disease in Children Cranial Nerve Diseases Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flexible fiberoptic laryngoscopy

Procedure

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

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Postoperative length of stay (prospective)

    Time frame: Up to 180 days

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

  7. Time to initiation of feeding therapy (prospective)

    Time frame: Day 7

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

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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