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
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
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