None listed
Conditions
Brief summary
This study is designed to assess the effectiveness of the Bispectral Index (BIS) monitor in helping nurses to decide if intensive care patient’s are receiving the right amount of sedation medication to keep them comfortable and asleep while they are connected to the ventilator. The BIS monitor is a non-invasive machine that measures electrical brain wave activity, and converts it into a number that indicates if patients are too awake or deeply unresponsive. The study will be conducted in the Intensive Care Unit at the Alfred Hospital. This study is designed as a prospective randomised control trial with parallel design. This means that participants’ will be randomly allocated into either one of two groups – an intervention or control group. Participant’s randomised to the intervention group will receive BIS monitoring. The control group will receive standard ICU sedation assessment and management. To determine if BIS monitoring is useful in ICU, information will be collected by auditing patient charts and determining the average amounts of sedation medication for each nursing shift. In addition, the years of critical care experience and critical care qualification will be recorded for each nurse managing patients recruited to the study.
Interventions
This study is designed as a prospective randomised control trial with parallel design. Participants randomised to the intervention group will receive bispectral index sedation (BIS) monitoring.
The bispectral index sedation monitor is derived from the electroencephalogram and provides a numeric value that represents cerebral activity. Nurses will be able to titrate and manage sedation based on an objective score (0- 100) that reflects the patients level of sedation. Patients randomised to rec
This study is designed as a prospective randomised control trial with parallel design. Participants randomised to the intervention group will receive bispectral index sedation (BIS) monitoring. The bispectral index sedation monitor is derived from the electroencephalogram and provides a numeric value that represents cerebral activity. Nurses will be able to titrate and manage sedation based on an objective score (0- 100) that reflects the patients level of sedation. Patients randomised to recieve BIS monitoring will be continously monitored until they are extubated or a tracheostomy is performed. Patients randomised to the control intervention will recieve standard care and their sedative needs will be assessed and managed based on subjective sedation assessments. The control arm will continue until sedatives are no longer required. Data collection will cease for all patients at the time of extubation or tracheostomy. Both groups of participants will be managed by nurses with a range of general nursing and critical care nursing experience, and with differing levels of critical care training.
Sponsors
Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Intubated and mechanically ventilatedLikely to be ventilated for at least 12 hoursReceiving sedative infusion of morphine and midazolam.
Exclusion criteria
Intracranial injury, neurological disorders, status epilepticus, facial burns.
Outcome results
None listed