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

• Conditions: Hearing Loss; Cardiac Surgery; Cardiopulmonary Bypass; Delirium; Postoperative Cognitive Dysfunction

• Registration Number: NCT04151914
• Lead Sponsor: European Georges Pompidou Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Status Verified: 2019-11
• Study Start: 2019-11-01
• Study First Submitted QC: 2019-11-02
• Study First Posted: 2019-11-05
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass	3 months	Change from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass

Secondary Outcome Measures

Name	Time	Method
Patient's quality of life after cardiac surgery: Survey	3 months	Survey 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)
ICU-acquired delirium	7 days	Diagnose 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 perfusion	7 days	Near infrared spectroscopy during per operative period and transcranial doppler during ICU stay

Trial Locations

Locations (1)

Georges Pompidou European Hospital; 🇫🇷 Paris, France