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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04151914
Acronym
AUDICS-ICU
Enrollment
50
Registered
2019-11-05
Start date
2019-11-01
Completion date
2020-08-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Delirium, Hearing Loss, Postoperative Cognitive Dysfunction

Brief summary

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.

Interventions

None listed

Sponsors

European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass3 monthsChange from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass

Secondary

MeasureTime frameDescription
ICU-acquired delirium7 daysDiagnose by CAM-ICU scale during ICU stay (if positive meaning the patient has delirium, CAM-ICU negative meaning the patient doesn't have delirium)
Cerebral perfusion7 daysNear infrared spectroscopy during per operative period and transcranial doppler during ICU stay
Patient's quality of life after cardiac surgery: Survey3 monthsSurvey evaluation quality of life at the end of ICU stay (IPREA) and 3 months after surgery. On a scale from 0 (best quality of life) to 100 (low quality of life)

Countries

France

Contacts

Primary ContactMatthieu Daniel, MD
matthieu.daniel2309@gmail.com+33(0)156092515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026