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NCT Number: NCT04463563

Cerebral Oximetry in Cardiac Surgery to Reduce Neurological Impairment and Hospital Length-of-stay

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.

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Key information

Conditions

Cardiac Surgery Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Ischemia Cerebrovascular Disorders Nervous System Diseases Neural Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18 years age. -

Exclusion criteria

Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.

Persistent neurological conditions:

Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease

-

Treatment and study plan

Physiological

Other

Changes to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position.

Primary outcomes

  1. 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.

  2. Physical neurological examination

    Time frame: 3 day post-operatively

    Mobility and conscious control of limbs.

  3. Neurological assessment.

    Time frame: 6 months post-operatively

    Telephone interview to assess patients perception of mobility, function and well being. (see below details)

  4. 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.

  5. Neurocognitive Test 2

    Time frame: Day 3 post op

    Visual attention and task switching: Trail Making test A and B

  6. Neurocognitive test 3

    Time frame: Day 3 post op

    Visual-spatial, frontal lobe: Anti-saccadic eye test

  7. Neurocognitive test 4

    Time frame: Day 3 post op

    Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.

  8. 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.

  9. 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.

  10. 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.

  11. Late neurocognitive test 3

    Time frame: 6 months post op

    Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.

Secondary outcomes

  1. 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.

    Days on ICU. The time from the day of surgery to the discharge to the ward or death. assessed .

  2. Major organ dysfunction

    Time frame: Before hospital discharge

    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.

  3. 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.

    Death in hospital at any time following surgery. Death is considered a mortality.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • The Hull and East Riding Cardiac Trust Fund

Registry information

Official study title

Cerebral Oximetry in Adult Cardiac Surgery to Reduce the Incidence of Neurological Impairment and Hospital Length-of-stay: A Prospective, Randomized, Controlled Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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