Clinical trial NCT04463563: Cerebral Oximetry in Cardiac Surgery to Reduce Neurological Impairment and Hospital Length-of-stay
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Neural Injury
Cerebral Ischemia
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: The Hull and East Riding Cardiac Trust Fund
First posted: 2020-07-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

-

Primary outcomes:
measure: Hospital length-of-stay
timeFrame: 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.
measure: Physical neurological examination
timeFrame: 3 day post-operatively
measure: Neurological assessment.
timeFrame: 6 months post-operatively
measure: Neurocognitive test 1
timeFrame: Day 3 post op.
measure: Neurocognitive Test 2
timeFrame: Day 3 post op
measure: Neurocognitive test 3
timeFrame: Day 3 post op
measure: Neurocognitive test 4
timeFrame: Day 3 post op
measure: Neurocognitive test 5
timeFrame: Day 3 post op
measure: Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.
timeFrame: 6 months post op
measure: Late neurocognitive test 2. Telephone questionnaire using elements of the previously used questionnaires.
timeFrame: 6 months post op
measure: Late neurocognitive test 3
timeFrame: 6 months post op
Secondary outcomes:
measure: Intensive Care length-of-stay
timeFrame: The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.
measure: Major organ dysfunction
timeFrame: Before hospital discharge
measure: Mortality
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Consultant Anaesthetist Hull Hospital Trust
name: Sean R Bennett, MB Chb
role: PRINCIPAL_INVESTIGATOR
References: