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

Delirium Clinical Trial

— AUDICS-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151914
• Other study ID #: AUDICS-ICU
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: August 2020

Study information

• Verified date: November 2019
• Source: European Georges Pompidou Hospital
• Contact: Matthieu Daniel, MD
• Phone: +33(0)156092515
• Email: matthieu.daniel2309[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Cognitive Dysfunction
• Delirium
• Hearing Disorders
• Hearing Loss
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
France	Georges Pompidou European Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass	Change from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass	3 months
Secondary	ICU-acquired delirium	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)	7 days
Secondary	Cerebral perfusion	Near infrared spectroscopy during per operative period and transcranial doppler during ICU stay	7 days
Secondary	Patient's quality of life after cardiac surgery: Survey	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)	3 months