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

November 8, 2019 updated by: Matthieu Daniel, European Georges Pompidou Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Georges Pompidou European Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthieu DANIEL
        • Sub-Investigator:
          • Ioannis Papapanayotou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Over 18 years old undergoing non urgent cardiac surgery with cardiopulmonary bypass.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass
Time Frame: 3 months
Change from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Matthieu Daniel, MD, European George Pompidou Hospital
  • Study Director: Bernard Cholley, PHD, European George Pompidou Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUDICS-ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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