Cardiac SurgeryNCT04463563
Cerebral Oximetry in Cardiac Surgery to Reduce Neurological Impairment and Hospital Length-of-stay
A study testing Physiological in people with Cardiac Surgery and Neural Injury, run by Hull University Teaching Hospitals NHS Trust.
Trial summary
Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery though not all studies agree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Neural Injury, Cerebral Ischemia
- What is being tested?
- Physiological
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2011to 1 Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18 years age. -
Who cannot join
- Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.
- Persistent neurological conditions:
- Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease
- -
About this study
Official title: Cerebral Oximetry in Adult Cardiac Surgery to Reduce the Incidence of Neurological Impairment and Hospital Length-of-stay: A Prospective, Randomized, Controlled Trial
Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery though not all studies agree. A previous audit using cerebral saturations at or above baseline showed improved neurological and length-of-stay outcomes.
Read the detailed description
This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group were managed perioperatively using our NIRS protocol. The control group had standard management without NIRS. Primary outcomes were post-operative neurological impairment and hospital length-of-stay. Secondary outcomes included ventilation times, intensive care unit length-of-stay, major organ dysfunction and mortality
- Conditions
- Cardiac Surgery, Neural Injury, Cerebral Ischemia
- Being tested
- Physiological
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiologicalOther
Changes to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position.
| Study group | Role | What they receive |
|---|---|---|
| NIRS group. Brain oxygen saturations group. | Active comparator | A monitor by means of non-invasive stickers will display cerebral oximetry (brain oxygen saturations) throughout the heart surgery.This gives a direct reading of brain frontal lobe oxygen levels. The baseline is recorded before the patient goes to sleep (anaesthetised) and throughout the surgery and time on cardiopulmonary bypass if the brain oxygen levels fall below baseline then various physiological changes are made to restore oxygen to baseline. Receives: Other: Physiological |
| Standard Patient Monitoring | No intervention | No cerebral monitoring. Standard patient monitoring according to normal practice at Castle Hill Hospital apply. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length-of-stay
How long before discharge post-operatively.
Measured: Measured in days from the day of operation to the day the patient is discharged from hospital or death in hospital. If neither has occurred within 6 months of participant's operation it will be recorded as 6 months hospital stay.
Physical neurological examination
Mobility and conscious control of limbs.
Measured: 3 day post-operatively
Neurological assessment.
Telephone interview to assess patients perception of mobility, function and well being. (see below details)
Measured: 6 months post-operatively
Neurocognitive test 1
Fluency and cognitive functions: Mini-Mental State Examination (MMSE). This test is conducted as a questionnaire of 11 questions. Questions include 'what is the date?', 'name the town you are in?', spelling-forwards and backwards, counting backwards, copying a picture, follow an instruction, naming objects etc. The test is scored out of 30 and recorded in a table. The test is repeated on the third post op day and the 2 scores compared to give a number which relates to performance.
Measured: Day 3 post op.
Neurocognitive Test 2
Visual attention and task switching: Trail Making test A and B
Measured: Day 3 post op
Neurocognitive test 3
Visual-spatial, frontal lobe: Anti-saccadic eye test
Measured: Day 3 post op
Neurocognitive test 4
Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.
Measured: Day 3 post op
Neurocognitive test 5
General well-being HADS (hospital anxiety and depression score) A and D. HADS A -hospital anxiety and depression score relating to Anxiety. HADS D- hospital anxiety and depression score relating to Depression. Patients are asked a question and their response is scored from 0-3. There are 14 questions the score is recorded and compared with the score after the same questions on the 3rd post-op day. The result gives an indication of the patient's mental state and how it may have changed dur to the sugery.
Measured: Day 3 post op
Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.
General health questions were: how is your overall health, memory, mood, motor function?Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
Measured: 6 months post op
Late neurocognitive test 2. Telephone questionnaire using elements of the previously used questionnaires.
Cognition questions were: Date, repeat and recall, serial 7s, spell, recall. Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
Measured: 6 months post op
Late neurocognitive test 3
Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.
Measured: 6 months post op
Secondary outcomes (3)
Intensive Care length-of-stay
Days on ICU. The time from the day of surgery to the discharge to the ward or death. assessed .
Measured: The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.
Major organ dysfunction
Renal function is assessed measuring creatinine. Gastrointestinal function is assessed by the diagnosis of ileus or ischaemic bowel at laparotomy. Cardiac function is assessed by the requirement for inotropic support. Respiratory function is assessed by the requirement for ventilation. All these outcomes are have clinical relevance during the stay on ICU.
Measured: Before hospital discharge
Mortality
Death in hospital at any time following surgery. Death is considered a mortality.
Measured: Day of surgery to death. If the participant is discharged from hospital alive it is not a mortality. Assessed for 6 months from the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Feb 2011
- Primary completion1 Mar 2014
- Study completion1 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- The Hull and East Riding Cardiac Trust Fund
- Responsible party
- Sponsor
- Investigators
- Sean R Bennett, MB Chb, Principal investigator, Consultant Anaesthetist Hull Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463563
- Sponsor's protocol ID
- REC-10/H0906/72
- Status last verified
- Jul 2020
- First submitted
- 20 Jun 2020
- Last updated
- 9 Jul 2020
- 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry in Adult Cardiac Surgery to Reduce the Incidence of Neurological Impairment and Hospital Length-of-stay: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04463563
- Acronym / sponsor ID
- REC-10/H0906/72
- Conditions
- Cardiac Surgery, Neural Injury, Cerebral Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- The Hull and East Riding Cardiac Trust Fund
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 9 Jul 2020 (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.
Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery though not all studies agree. A previous audit using cerebral saturations at or above baseline showed improved neurological and length-of-stay outcomes.
Detailed description
This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group were managed perioperatively using our NIRS protocol. The control group had standard management without NIRS. Primary outcomes were post-operative neurological impairment and hospital length-of-stay. Secondary outcomes included ventilation times, intensive care unit length-of-stay, major organ dysfunction and mortality
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope.
| Arm | Type | Receives |
|---|---|---|
| NIRS group. Brain oxygen saturations group. | Active comparator | Other: PhysiologicalA monitor by means of non-invasive stickers will display cerebral oximetry (brain oxygen saturations) throughout the heart surgery.This gives a direct reading of brain frontal lobe oxygen levels. The baseline is recorded before the patient goes to sleep (anaesthetised) and throughout the surgery and time on cardiopulmonary bypass if the brain oxygen levels fall below baseline then various physiological changes are made to restore oxygen to baseline. |
| Standard Patient Monitoring | No intervention | –No cerebral monitoring. Standard patient monitoring according to normal practice at Castle Hill Hospital apply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18 years age. -
Key exclusion criteria (4 listed)
- Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.
- Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease
- -
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 |
|---|---|---|
| PhysiologicalChanges to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position. | Other | NIRS group. Brain oxygen saturations group. |
Primary outcome
Hospital length-of-stay
Time frame: Measured in days from the day of operation to the day the patient is discharged from hospital or death in hospital. If neither has occurred within 6 months of participant's operation it will be recorded as 6 months hospital stay.
How long before discharge post-operatively.
Physical neurological examination
Time frame: 3 day post-operatively
Mobility and conscious control of limbs.
Neurological assessment.
Time frame: 6 months post-operatively
Telephone interview to assess patients perception of mobility, function and well being. (see below details)
Neurocognitive test 1
Time frame: Day 3 post op.
Fluency and cognitive functions: Mini-Mental State Examination (MMSE). This test is conducted as a questionnaire of 11 questions. Questions include 'what is the date?', 'name the town you are in?', spelling-forwards and backwards, counting backwards, copying a picture, follow an instruction, naming objects etc. The test is scored out of 30 and recorded in a table. The test is repeated on the third post op day and the 2 scores compared to give a number which relates to performance.
Neurocognitive Test 2
Time frame: Day 3 post op
Visual attention and task switching: Trail Making test A and B
Neurocognitive test 3
Time frame: Day 3 post op
Visual-spatial, frontal lobe: Anti-saccadic eye test
Neurocognitive test 4
Time frame: Day 3 post op
Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.
Neurocognitive test 5
Time frame: Day 3 post op
General well-being HADS (hospital anxiety and depression score) A and D. HADS A -hospital anxiety and depression score relating to Anxiety. HADS D- hospital anxiety and depression score relating to Depression. Patients are asked a question and their response is scored from 0-3. There are 14 questions the score is recorded and compared with the score after the same questions on the 3rd post-op day. The result gives an indication of the patient's mental state and how it may have changed dur to the sugery.
Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.
Time frame: 6 months post op
General health questions were: how is your overall health, memory, mood, motor function?Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
Late neurocognitive test 2. Telephone questionnaire using elements of the previously used questionnaires.
Time frame: 6 months post op
Cognition questions were: Date, repeat and recall, serial 7s, spell, recall. Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
Late neurocognitive test 3
Time frame: 6 months post op
Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.
3 secondary outcomes
Intensive Care length-of-stay
Time frame: The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.
Major organ dysfunction
Time frame: Before hospital discharge
Mortality
Time frame: Day of surgery to death. If the participant is discharged from hospital alive it is not a mortality. Assessed for 6 months from the day of 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 9 Jul 2020.
- 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.
Sean R Bennett, MB Chb principal investigator
Consultant Anaesthetist Hull Hospital Trust
Questions about this trial
What is this clinical trial studying?
A study testing Physiological in people with Cardiac Surgery and Neural Injury, run by Hull University Teaching Hospitals NHS Trust.
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 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospital length-of-stay (time frame: Measured in days from the day of operation to the day the patient is discharged from hospital or death in hospital. If neither has occurred within 6 months of participant's operation it will be recorded as 6 months hospital stay.). The study lists 11 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 9 Jul 2020.