Correlation between right-to-left shunt and sudden sensorineural hearing loss: protocol for a case-control study.
head & neck surgery
neurology
ultrasonography
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
09 11 2023
09 11 2023
Historique:
medline:
13
11
2023
pubmed:
10
11
2023
entrez:
9
11
2023
Statut:
epublish
Résumé
Sudden sensorineural hearing loss (SSNHL) is a neurological and otolaryngological emergency during which rapid diagnosis and early treatment are of great importance. Clinical experience indicates that a considerable number of patients with SSNHL have concurrent right-to-left shunt (RLS). With limited reports, the association between SSNHL and RLS is yet unclear and there is a need for large observational studies to explore their latent relationship. This proposed study is a prospective, observational case-control study. A total of 194 eligible participants matched in age and sex will be divided equally into two groups: 97 patients with SSNHL included in the case group and 97 individuals without SSNHL in the control group. Medical evaluations, including clinical characteristics, laboratory examination, audiological examination and ultrasonography examination, will be performed in all subjects. The primary outcome of the study is the difference in RLS rates between the groups. Differences in patent foramen ovale rates and other measured variables will be further assessed. A conditional logistic regression as a correlation analysis will be used to evaluate the relationship between RLS and SSNHL. This study may provide evidence on the correlation between RLS and SSNHL in order to enrich the aetiology of SSNHL. The study protocol has been approved by the Ethics Committee of Peking University Shenzhen Hospital. A written informed consent form will be signed and dated by the participants and the researchers before the study begins. The results will be disseminated in peer-reviewed publications. ChiCTR2200064067.
Sections du résumé
BACKGROUND AND PURPOSE
Sudden sensorineural hearing loss (SSNHL) is a neurological and otolaryngological emergency during which rapid diagnosis and early treatment are of great importance. Clinical experience indicates that a considerable number of patients with SSNHL have concurrent right-to-left shunt (RLS). With limited reports, the association between SSNHL and RLS is yet unclear and there is a need for large observational studies to explore their latent relationship.
METHODS AND ANALYSIS
This proposed study is a prospective, observational case-control study. A total of 194 eligible participants matched in age and sex will be divided equally into two groups: 97 patients with SSNHL included in the case group and 97 individuals without SSNHL in the control group. Medical evaluations, including clinical characteristics, laboratory examination, audiological examination and ultrasonography examination, will be performed in all subjects. The primary outcome of the study is the difference in RLS rates between the groups. Differences in patent foramen ovale rates and other measured variables will be further assessed. A conditional logistic regression as a correlation analysis will be used to evaluate the relationship between RLS and SSNHL.
DISCUSSION
This study may provide evidence on the correlation between RLS and SSNHL in order to enrich the aetiology of SSNHL.
ETHICS AND DISSEMINATION
The study protocol has been approved by the Ethics Committee of Peking University Shenzhen Hospital. A written informed consent form will be signed and dated by the participants and the researchers before the study begins. The results will be disseminated in peer-reviewed publications.
TRIAL REGISTRATION NUMBER
ChiCTR2200064067.
Identifiants
pubmed: 37945293
pii: bmjopen-2022-070771
doi: 10.1136/bmjopen-2022-070771
pmc: PMC10649378
doi:
Banques de données
ChiCTR
['ChiCTR2200064067']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e070771Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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