Postoperative Delirium After On-pump Cardiac SurgeryNCT02478736
Preoperative Transcranial Doppler as a Predictor for Delirium Following On-pump Cardiac Surgery
An observational study of Postoperative Delirium After On-pump Cardiac Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Postoperative Delirium After On-pump Cardiac Surgery
- What is being tested?
- No actual intervention
- How many people
- 175 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Mar 2017
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing on-pump cardiac surgery
Who may be able to join
- 1. Patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery
Who cannot join
- No communication possible due to a language barrier or deafness
- Patients diagnosed with neurocognitive disorders or psychiatric diseases (MMSE or Geriatric Depression Scale cannot be checked before surgery)
- Patients with unstable hemodynamics or intubated before surgery
- Patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by CT angiography or MR angiography
- Patients diagnosed with stroke, TIA or neurologic diseases (e.g. Parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. Another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.
- Being tested
- No actual intervention
- Keywords
- postoperative delirium, on-pump cardiac surgery, cerebral oximetry, cerebral blood flow velosity
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No actual interventionOther
Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.
| Study group | Role | What they receive |
|---|---|---|
| delirium group | the patients with delirum after on-pump cardiac surgery Receives: Other: No actual intervention | |
| no delirium group | the patients without delirum after on-pump cardiac surgery Receives: Other: No actual intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive power of perioperative MFV of MCA regarding postoperative delirium
The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. The investigators plan to evaluate whether perioperative rSO2 and/or MFV of MCA can predict postoperative delirium in patients undergoing the on-pump cardiac surgery and to assess the predictive power of perioperative rSO2/MFV of MCA regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 4 hours) and MVF of MCA was measured just before the induction of general anesthesia.
Measured: 7 days from postoperation
the predictive power of periopertiver rSO2 values regarding postoperative delirium
To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery
Measured: 7 days from postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium After On-pump Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478736
- Sponsor's protocol ID
- 4-2015-0319
- Status last verified
- Jan 2018
- First submitted
- 18 Jun 2015
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Transcranial Doppler as a Predictor for Delirium Following On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02478736
- Acronym / sponsor ID
- 4-2015-0319
- Keywords
- postoperative delirium, on-pump cardiac surgery, cerebral oximetry, cerebral blood flow velosity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. Another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium group | – | Other: No actual interventionthe patients with delirum after on-pump cardiac surgery |
| no delirium group | – | Other: No actual interventionthe patients without delirum after on-pump cardiac surgery |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing on-pump cardiac surgery
Key inclusion criteria (1 listed)
- 1. Patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery
Key exclusion criteria (5 listed)
- No communication possible due to a language barrier or deafness
- Patients diagnosed with neurocognitive disorders or psychiatric diseases (MMSE or Geriatric Depression Scale cannot be checked before surgery)
- Patients with unstable hemodynamics or intubated before surgery
- Patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by CT angiography or MR angiography
- Patients diagnosed with stroke, TIA or neurologic diseases (e.g. Parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No actual interventionContact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject. | Other | delirium group, no delirium group |
Primary outcome
the predictive power of perioperative MFV of MCA regarding postoperative delirium
Time frame: 7 days from postoperation
The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. The investigators plan to evaluate whether perioperative rSO2 and/or MFV of MCA can predict postoperative delirium in patients undergoing the on-pump cardiac surgery and to assess the predictive power of perioperative rSO2/MFV of MCA regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 4 hours) and MVF of MCA was measured just before the induction of general anesthesia.
the predictive power of periopertiver rSO2 values regarding postoperative delirium
Time frame: 7 days from postoperation
To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Delirium After On-pump Cardiac Surgery, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the predictive power of perioperative MFV of MCA regarding postoperative delirium (time frame: 7 days from postoperation). The study lists 2 primary outcomes in all. 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 8 Jan 2018.