Laryngeal Disorders After Childhood Cardiac Surgery

NCT ID: NCT04638361

Last Updated: 2022-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-26

Study Completion Date

2021-09-17

Brief Summary

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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).

Detailed Description

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Conditions

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Laryngeal Injury Swallowing Disorder Voice Disorders in Children Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No laryngeal mobility disorder post cardiac surgery

No Follow up, no questionnaires and no nasofibroscopic control.

No interventions assigned to this group

Laryngeal mobility disorder post cardiac surgery

During a follow-up consultation, questionnaires will be offered to assess the child's quality of life.

Questionnaires

Intervention Type OTHER

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.

Interventions

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Questionnaires

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No opposition from children and parents
* Patient or parents able to understand the ins and outs of the study

Exclusion Criteria

* None
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonia AYARI-KHALFALLAH, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,

Locations

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Hôpital Femme Mère Enfant

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01701-38

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0505

Identifier Type: -

Identifier Source: org_study_id

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