Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study

NCT ID: NCT04151914

Last Updated: 2019-11-13

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-08-31

Brief Summary

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AUDICS-ICU is a prospective observational aiming to evaluate the prevalence of auditive dysfunction following cardiac surgery. Participants will undergo audiometric testings before and 3 months after cardiac surgery with cardiopulmonary bypass. Furthermore, the study evaluates hearing loss-associated ICU-acquired delirium after cardiac surgery with cardiopulmonary bypass.

Detailed Description

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Conditions

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Hearing Loss Cardiac Surgery Cardiopulmonary Bypass Postoperative Cognitive Dysfunction Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Over 18 years old
* Undergoing non urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

* Pregnant
* History of ear surgery
* Ear disease
* Inadequate understanding of the protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthieu Daniel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthieu Daniel, MD

Role: PRINCIPAL_INVESTIGATOR

European George Pompidou Hospital

Bernard Cholley, PHD

Role: STUDY_DIRECTOR

European George Pompidou Hospital

Locations

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Georges Pompidou European Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Matthieu Daniel, MD

Role: CONTACT

+33(0)156092515

Facility Contacts

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Matthieu Daniel, MD

Role: primary

+33(0)156095813

Ioannis PAPAPANAYOTOU

Role: backup

+33(0)608324214

Other Identifiers

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AUDICS-ICU

Identifier Type: -

Identifier Source: org_study_id

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