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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-01

Study Completion Date

2014-09-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Cardiac Surgery Neural Injury Cerebral Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The personnel assessing and collecting the post-operative data were unaware of the patient group in the operating room.

Study Groups

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NIRS group. Brain oxygen saturations group.

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.

Group Type ACTIVE_COMPARATOR

Physiological

Intervention Type OTHER

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

Standard Patient Monitoring

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physiological

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

Intervention Type OTHER

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No