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

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463563
• Other study ID #: REC-10/H0906/72
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: September 1, 2014

Study information

• Verified date: July 2020
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 1, 2014
• Est. primary completion date: March 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Brain Ischemia
• Cardiac Surgery
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia
• Neural Injury

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	The Hull and East Riding Cardiac Trust Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Physical neurological examination	Mobility and conscious control of limbs.	3 day post-operatively
Primary	Neurological assessment.	Telephone interview to assess patients perception of mobility, function and well being. (see below details)	6 months post-operatively
Primary	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.
Primary	Neurocognitive Test 2	Visual attention and task switching: Trail Making test A and B	Day 3 post op
Primary	Neurocognitive test 3	Visual-spatial, frontal lobe: Anti-saccadic eye test	Day 3 post op
Primary	Neurocognitive test 4	Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.	Day 3 post op
Primary	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
Primary	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
Primary	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
Primary	Late neurocognitive test 3	Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.	6 months post op
Secondary	Intensive Care length-of-stay	Days on ICU. The time from the day of surgery to the discharge to the ward or death. assessed .	The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.
Secondary	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.	Before hospital discharge
Secondary	Mortality	Death in hospital at any time following surgery. Death is considered a 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.