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

NCT ID: NCT03882450

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-03-13

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.

Conditions

Vocal Fold Palsy; Dysphagia; Congenital Heart Disease in Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Flexible fiberoptic laryngoscopy

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Laryngeal ultrasonography

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

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nikhila Raol

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikhila Raol, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00093935

Identifier Type: -

Identifier Source: org_study_id