Laryngeal Disorders After Childhood Cardiac Surgery

NCT04638361 | Completed

• 2 other identifiers: 69HCL20_05052020-A01701-38
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Laryngeal dysfunction; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Study Arms (2)

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.

Other: Questionnaires

Interventions

Questionnaires 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.

Laryngeal mobility disorder post cardiac surgery

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sonia AYARI-KHALFALLAH, MD

  Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: August 26, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

FR (1)