Laryngeal InjuryRECUP-TMLNCT04638361
Laryngeal Disorders After Childhood Cardiac Surgery
An observational study of Laryngeal Injury and Swallowing Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Laryngeal Injury, Swallowing Disorder, Voice Disorders in Children
- What is being tested?
- Questionnaires
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2021to 17 Sep 2021
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 5 and 10 years old, having undergone a nasofibroscopy following cardiac surgery performed before their first year of life (between 01/01/2010 and 12/31/2015).
Who may be able to join
- No opposition from children and parents
- Patient or parents able to understand the ins and outs of the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery
Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).
- Conditions
- Laryngeal Injury, Swallowing Disorder, Voice Disorders in Children, Surgery--Complications
- Being tested
- Questionnaires
- Keywords
- Laryngeal dysfunction, Cardiac surgery
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
To explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.
| Study group | Role | What they receive |
|---|---|---|
| No laryngeal mobility disorder post cardiac surgery | No Follow up, no questionnaires and no nasofibroscopic control. | |
| Laryngeal mobility disorder post cardiac surgery | During a follow-up consultation, questionnaires will be offered to assess the child's quality of life. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of a laryngeal mobility disorder after childhood cardiac surgery
The prevalence will be evaluated on the respiratory, food or phonatory difficulties reported after surgery as well as on the result of early postoperative nasofibroscopy.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start26 Aug 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia AYARI-KHALFALLAH, MD, Principal investigator, Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638361
- Sponsor's protocol ID
- 69HCL20_0505
- Other IDs
- 2020-A01701-38
- Acronym
- RECUP-TML
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2020
- Last updated
- 28 Nov 2022
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery
- ClinicalTrials.gov ID
- NCT04638361
- Acronym / sponsor ID
- RECUP-TML / 69HCL20_0505
- Conditions
- Laryngeal Injury, Swallowing Disorder, Voice Disorders in Children, Surgery--Complications
- Keywords
- Laryngeal dysfunction, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 20 Nov 2020 (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.
Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No laryngeal mobility disorder post cardiac surgery | – | –No Follow up, no questionnaires and no nasofibroscopic control. |
| Laryngeal mobility disorder post cardiac surgery | – | Other: QuestionnairesDuring a follow-up consultation, questionnaires will be offered to assess the child's quality of life. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 5 and 10 years old, having undergone a nasofibroscopy following cardiac surgery performed before their first year of life (between 01/01/2010 and 12/31/2015).
Key inclusion criteria (2 listed)
- No opposition from children and parents
- Patient or parents able to understand the ins and outs of the study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuestionnairesTo explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life. | Other | Laryngeal mobility disorder post cardiac surgery |
Primary outcome
Prevalence of a laryngeal mobility disorder after childhood cardiac surgery
Time frame: One day
The prevalence will be evaluated on the respiratory, food or phonatory difficulties reported after surgery as well as on the result of early postoperative nasofibroscopy.
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 28 Nov 2022.
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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.
Sonia AYARI-KHALFALLAH, MD principal investigator
Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Injury and Swallowing Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 1 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 28 Nov 2022. 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 France. 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?
Prevalence of a laryngeal mobility disorder after childhood cardiac surgery (time frame: One day). 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 28 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.