Hearing LossAUDICS-ICUNCT04151914
Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study
An observational study of Hearing Loss and Cardiac Surgery, run by European Georges Pompidou Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cardiac Surgery, Cardiopulmonary Bypass
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 years old undergoing non urgent cardiac surgery with cardiopulmonary bypass.
Who may be able to join
- Over 18 years old
- Undergoing non urgent cardiac surgery with cardiopulmonary bypass
Who cannot join
- Pregnant
- History of ear surgery
- Ear disease
- Inadequate understanding of the protocol
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Georges Pompidou European Hospital
Paris, 75015
Matthieu Daniel, MD, +33(0)156095813, matthieu.daniel2309@gmail.com
Ioannis PAPAPANAYOTOU, +33(0)608324214, papapanayotou.i@gmail.com
About this study
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.
- Conditions
- Hearing Loss, Cardiac Surgery, Cardiopulmonary Bypass, Postoperative Cognitive Dysfunction, Delirium
- Medical subject headings
- Hearing Loss, Postoperative Cognitive Complications, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass
Change from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass
Measured: 3 months
Secondary outcomes (3)
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)
Measured: 7 days
Cerebral perfusion
Near infrared spectroscopy during per operative period and transcranial doppler during ICU stay
Measured: 7 days
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Daniel, European Georges Pompidou Hospital
- Investigators
- Matthieu Daniel, MD, Principal investigator, European George Pompidou HospitalBernard Cholley, PHD, Study director, European George Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151914
- Sponsor's protocol ID
- AUDICS-ICU
- Acronym
- AUDICS-ICU
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04151914
- Acronym / sponsor ID
- AUDICS-ICU / AUDICS-ICU
- Conditions
- Hearing Loss, Cardiac Surgery, Cardiopulmonary Bypass, Postoperative Cognitive Dysfunction, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years old undergoing non urgent cardiac surgery with cardiopulmonary bypass.
Key inclusion criteria (2 listed)
- Over 18 years old
- Undergoing non urgent cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Pregnant
- History of ear surgery
- Ear disease
- Inadequate understanding of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
ICU-acquired delirium
Time frame: 7 days
Cerebral perfusion
Time frame: 7 days
Patient's quality of life after cardiac surgery: Survey
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Daniel, MD principal investigator
European George Pompidou Hospital
Bernard Cholley, PHD study director
European George Pompidou Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Cardiac Surgery, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Daniel, MD (+33(0)156092515, matthieu.daniel2309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.