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

NCT03882450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-04-14

No results posted yet for this study

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.

Conditions

  • Vocal Fold Palsy
  • Dysphagia
  • Congenital Heart Disease in Children

Interventions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Nikhila Raol, MD, MPH · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882450 on ClinicalTrials.gov