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

NCT04463563 | Completed

• 1 other identifier: REC-10/H0906/72
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief 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. A previous audit using cerebral saturations at or above baseline showed improved neurological and length-of-stay outcomes.

Conditions

Cardiac Surgery; Neural Injury; Cerebral Ischemia

Outcome Measures

Primary Outcomes (11)

• Hospital length-of-stay

  How long before discharge post-operatively.

  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.

  3 day post-operatively

• Neurological assessment.

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

  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.

  Day 3 post op.

• Neurocognitive Test 2

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

  Day 3 post op

• Neurocognitive test 3

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

  Day 3 post op

• Neurocognitive test 4

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

  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.

  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.

  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.

  6 months post op

• Late neurocognitive test 3

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

  6 months post op

Secondary Outcomes (3)

• Intensive Care length-of-stay

  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

  Before hospital discharge

• Mortality

  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.

Study Arms (2)

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.

Other: Physiological

Standard Patient Monitoring

NO INTERVENTION

No cerebral monitoring. Standard patient monitoring according to normal practice at Castle Hill Hospital apply.

Interventions

Physiological OTHER

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

NIRS group. Brain oxygen saturations group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.
• Persistent neurological conditions:
• Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• The Hull and East Riding Cardiac Trust Fund: collaborator

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean R Bennett, MB Chb

  Consultant Anaesthetist Hull Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The personnel assessing and collecting the post-operative data were unaware of the patient group in the operating room.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: July 9, 2020
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share