Clinical trial NCT01997931: The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
Official title: The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care
Mechanically Ventilated Patients
Sedated Patients
Keywords: bispectral index
sedation
intensive care
mechanical ventilation
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2013-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients.

The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS) monitoring will receive less sedation then those receiving standard sedation management.

The secondary hypotheses are:

1. Patients with BIS have fewer ventilation days than those receiving standard sedation management.
2. Level of sedation administered will differ according to the critical care experience and qualification of the nurse.

Detailed description: Patients in intensive care units (ICUs) frequently require sedatives and analgesics as part of therapy. Assessing the appropriate dose of sedative and analgesic drugs can be difficult due to the severity of the patient's illness, inability of the patient to communicate, multiple procedures and transports for investigations and the subjectivity of clinical sedation assessment tools. Poorly assessed and managed levels of sedation can result in over sedation, extended ventilation time and a potentially extended ICU stay.

The BIS monitor is derived from the electroencephalogram and provides a numeric value that represents a measure of cerebral activity. Such an objective measure of the patient's level of sedation may provide a useful tool that will enable nurses to titrate sedation more accurately in an attempt to provide the optimal level of sedation for all ICU patients.

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.

Eligibility criteria: Inclusion Criteria:

* Intubated and ventilated for at least 24 hours
* Sedated on morphine and midazelam infusions

Exclusion Criteria:

* Intracranial injury
* Status epilepticus
* Facial Burns

Primary outcomes:
measure: Optimised sedation management for patients through the use of BIS monitoring.
Secondary outcomes:
measure: Reduction in mechanical ventilation time.
measure: Reduced length of stay in the intensive care unit.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Cindy A Weatherburn
role: PRINCIPAL_INVESTIGATOR
References: