Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03882450
Recruitment Status : Enrolling by invitation
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nikhila Raol, Emory University

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.

Condition or disease Intervention/treatment Phase
Vocal Fold Palsy Dysphagia Congenital Heart Disease in Children Procedure: Flexible fiberoptic laryngoscopy Procedure: Laryngeal ultrasonography Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882450


Locations
Layout table for location information
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Nikhila Raol, MD, MPH Emory University

Layout table for additonal information
Responsible Party: Nikhila Raol, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03882450     History of Changes
Other Study ID Numbers: IRB00093935
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Signs and Symptoms