Cardiac DiseaseNCT01707446
Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
A study testing Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and An alarm threshold at 75% of the baseline rSO2 value in people with Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and An alarm threshold at 75% of the baseline rSO2 value
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Aug 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 60 years
- combined valve and CABG
- repeat cardiac surgery
- multiple valve replacement or repair
- surgery of ascending aorta and aortic arch
- signed informed consent.
Who cannot join
- cardiac surgery without the use of cardiopulmonary bypass
- symptomatic cerebrovascular disease,
- history of delirium, or
- schizophrenia
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Heatlh Network, Toronto General Hopsital
Toronto, Ontario, M5G 2C4
About this study
Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).
Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.
- Conditions
- Cardiac Disease
- Being tested
- Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter), An alarm threshold at 75% of the baseline rSO2 value
- Keywords
- Cardiac surgery, Delirium, Cerebral Oximetry
- Medical subject headings
- Heart Diseases, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)Device
In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.
An alarm threshold at 75% of the baseline rSO2 valueOther
If the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Near-infrared reflectance spectroscopy | Active comparator | Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Receives: Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter); Other: An alarm threshold at 75% of the baseline rSO2 value |
| Blinded Near-infrared reflectance spectroscopy | No intervention | In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who suffer from delirium postoperatively
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
Measured: Delirium we be assessed postoperatively for 7 days or Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707446
- Sponsor's protocol ID
- 11-0650-A
- Status last verified
- May 2016
- First submitted
- 12 Dec 2011
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01707446
- Acronym / sponsor ID
- 11-0650-A
- Conditions
- Cardiac Disease
- Keywords
- Cardiac surgery, Delirium, Cerebral Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Oct 2012 (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.
Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).
Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near-infrared reflectance spectroscopy | Active comparator | Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter), Other: An alarm threshold at 75% of the baseline rSO2 valueBilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. |
| Blinded Near-infrared reflectance spectroscopy | No intervention | –In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > 60 years
- combined valve and CABG
- repeat cardiac surgery
- multiple valve replacement or repair
- surgery of ascending aorta and aortic arch
Key exclusion criteria (4 listed)
- cardiac surgery without the use of cardiopulmonary bypass
- symptomatic cerebrovascular disease,
- history of delirium, or
- schizophrenia
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 |
|---|---|---|
| Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements. | Device | Near-infrared reflectance spectroscopy |
| An alarm threshold at 75% of the baseline rSO2 valueIf the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented. | Other | Near-infrared reflectance spectroscopy |
Primary outcome
Number of patients who suffer from delirium postoperatively
Time frame: Delirium we be assessed postoperatively for 7 days or Discharge
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
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 1 Jun 2017.
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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.
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?
A study testing Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and An alarm threshold at 75% of the baseline rSO2 value in people with Cardiac Disease, run by University Health Network, Toronto at 1 site in Canada.
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 6 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: finished, as of the sponsor's last update on 1 Jun 2017. 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 Canada. 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?
Number of patients who suffer from delirium postoperatively (time frame: Delirium we be assessed postoperatively for 7 days or Discharge). 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 1 Jun 2017.