Vocal Fold PalsyNCT03882450
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
A study testing Flexible fiberoptic laryngoscopy and Laryngeal ultrasonography in people with Vocal Fold Palsy and Dysphagia, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Vocal Fold Palsy, Dysphagia, Congenital Heart Disease in Children
- What is being tested?
- Flexible fiberoptic laryngoscopy and Laryngeal ultrasonography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Being tested
- Flexible fiberoptic laryngoscopy, Laryngeal ultrasonography
- Medical subject headings
- Vocal Cord Paralysis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible fiberoptic laryngoscopyProcedure or surgery
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 ultrasonographyProcedure or surgery
Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with congenital cardiac disease (retrospective) | No intervention | 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. |
| Neonates with congenital cardiac disease (prospective) | Active comparator | 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. Receives: Procedure: Flexible fiberoptic laryngoscopy; Procedure: Laryngeal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay (retrospective)
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.
Measured: Baseline
Number of readmissions related to feeding difficulty (retrospective)
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.
Measured: Baseline
Number of readmissions related to aspiration (retrospective)
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.
Measured: Baseline
Time to initiation of feeding therapy (retrospective)
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.
Measured: Baseline
Number of participants with vocal fold motion impairment (prospective)
The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Measured: Baseline
Postoperative length of stay (prospective)
The number of days of postoperative stay at the hospital will be recorded.
Measured: Up to 180 days
Time to initiation of feeding therapy (prospective)
The number of days to start feeding therapy will be recorded.
Measured: Day 7
Number of readmissions related to aspiration (prospective)
The number of readmissions to the hospital for aspiration will be recorded.
Measured: 3 months, 6 months, 12 months
Number of readmissions related to feeding difficulty (prospective)
The number of readmissions to the hospital for feeding difficulties will be recorded.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jan 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold PalsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikhila Raol, Emory University
- Investigators
- Nikhila Raol, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882450
- Sponsor's protocol ID
- IRB00093935
- Status last verified
- Apr 2020
- First submitted
- 8 Mar 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03882450
- Acronym / sponsor ID
- IRB00093935
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates with congenital cardiac disease (retrospective) | No intervention | –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. |
| Neonates with congenital cardiac disease (prospective) | Active comparator | Procedure: Flexible fiberoptic laryngoscopy, Procedure: Laryngeal ultrasonographyEligible 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible fiberoptic laryngoscopyFlexible 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 or surgery | Neonates with congenital cardiac disease (prospective) |
| Laryngeal ultrasonographyLaryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake. | Procedure or surgery | Neonates with congenital cardiac disease (prospective) |
Primary outcome
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.
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.
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.
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.
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.
Postoperative length of stay (prospective)
Time frame: Up to 180 days
The number of days of postoperative stay at the hospital will be recorded.
Time to initiation of feeding therapy (prospective)
Time frame: Day 7
The number of days to start feeding therapy will be recorded.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhila Raol, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible fiberoptic laryngoscopy and Laryngeal ultrasonography in people with Vocal Fold Palsy and Dysphagia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative length of stay (retrospective) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.