Cerebral Oximetry in Adult Cardiac Surgery to Reduce the Incidence of Neurological Impairment and Hospital Length-of-stay: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Hospital length-of-stay
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The personnel assessing and collecting the post-operative data were unaware of the patient group in the operating room.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18 years age. -
排除标准
- •Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform test.
- •Persistent neurological conditions:
- •Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease
结局指标
主要结局
Hospital length-of-stay
时间窗: 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
时间窗: 3 day post-operatively
Mobility and conscious control of limbs.
Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.
时间窗: 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 3
时间窗: 6 months post op
Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.
Neurological assessment.
时间窗: 6 months post-operatively
Telephone interview to assess patients perception of mobility, function and well being. (see below details)
Neurocognitive Test 2
时间窗: Day 3 post op
Visual attention and task switching: Trail Making test A and B
Neurocognitive test 4
时间窗: Day 3 post op
Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.
Neurocognitive test 5
时间窗: 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 2. Telephone questionnaire using elements of the previously used questionnaires.
时间窗: 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.
Neurocognitive test 1
时间窗: 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 3
时间窗: Day 3 post op
Visual-spatial, frontal lobe: Anti-saccadic eye test
次要结局
- 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.)