Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000846527
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
14/08/2015
Date last updated
14/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Peri-Operative Evaluation of Sedation Depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT)
Scientific title
Peri-Operative Evaluation of Sedation Depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT) in comparison with clinically used tools.
Secondary ID [1] 286937 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery . 295362 0
Condition category
Condition code
Anaesthesiology 295630 295630 0 0
Anaesthetics
Cardiovascular 295694 295694 0 0
Coronary heart disease
Surgery 295695 295695 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Brainstem Biometrics Tremor Monitoring Unit (TMU) provides a method of measuring OMT through the eyelid (open or closed) and automatically displaying and analysing the resulting measurement on a monitor. The primary measurement variable is mean OMT frequency averaged over a short time interval (0.5-5 seconds). The TMU is composed of a surface mount amplifier and a piezoelectric transducer. The sensor is adhered to the patient’s eyelid and the surface mount amplifier is snapped onto a standard EEG patch at the temple. A connecting wire passes behind the patient’s ear into the recording device. The signal from the sensor is amplified, filtered, processed and displayed real-time on both an oscilloscope (waveform) and a numerical reading (frequency and amplitude numbers) taken as an average of each interval of data and filtering out saccadic or seismic events which are outside of the naturally occurring range of OMT values. The TMU will be put on by the research coordinator or Sub Investigator (anaesthetist), it will be continuous monitoring until extubation. This is not part of routine standard care.
Intervention code [1] 292130 0
Treatment: Devices
Comparator / control treatment
BIS monitoring is routine in anaesthesia using smal external pads covered by a plastic strip over the forehead. Measurements are recorded continuously prior to anaesthesia,during induction, re-emergence and until extubation in the ICU.It will administered by the Research Coordinator or the anaesthetist and is commonly used as part of standard care but not always. The RASS (Richmond Agitation-Sedation scale) is a clinical scale of sedation in ICU. This involves talking or applying physical stimulation to the patient to determine sedation level of patient based on RASS clinical scale, etc.Patients will act as their own controls and different measurements will be compared in the same patients.
RASS scores will be taken at 30 minute intervals, after emergence from anaesthesia, these scores will be taken by the ICU bedside nurse.
Control group
Active

Outcomes
Primary outcome [1] 295347 0
The primary outcome is the level of agreement between OMT and RASS at all clinical RASS levels achieved while sedated in intensive care
Timepoint [1] 295347 0
RASS scores will be taken at 30 minute intervals, after emergence from anaesthesia until extubation in the ICU.
Secondary outcome [1] 315399 0
Predictive capacity of OMT vs BIS to differentiate specific clinical events: induction, intubation, skin incision, bypass on and off, sternal closure and transfer to ICU.
Timepoint [1] 315399 0
OMT and BIS measurements will be recorded continuously prior to anaesthesia, during induction, re-emergence and until extubation in the ICU.
Secondary outcome [2] 315746 0
Determine the nature and strength and of the relationship between OMT and BIS under differing anesthetic agents and during hypothermia
Timepoint [2] 315746 0
From prior to anaesthesia until re-emergence from anaesthesia
Secondary outcome [3] 315747 0
Ease of OMT application and monitoring on visual scale of 1-10
Timepoint [3] 315747 0
From prior to induction of anaesthesia to completion of surgery
Secondary outcome [4] 315748 0
Bedside nurse satisfaction with OMT on a visual scale 1-10
Timepoint [4] 315748 0
At completion of monitoring of OMT at the bedside.

Eligibility
Key inclusion criteria
All patients undergoing elective/semi-elective cardiac surgery and expected to be ventilated and sedated post-operatively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years, salvage surgery,Anaesthesia plan doesn't include Sevoflurane, Propofol or Dexmedetomidine, Patients with artifical eye/lens, Patients with third nerve palsy, refused consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Data will initially be assessed for normality with quantification of the relationship between OMT and RASS determined using generalised linear modelling accounting for repeated measures. Should OMT be found to have significant departures from normality, comparisons will be performed using Wilcoxon sign-rank tests. The predictive capacity of OMT and BIS to differentiate specific clinical events will be performed using logistic regression and reported as area under the receiver operator curve. The nature and strength and of the relationship between OMT and BIS under differing anesthetic agents and during hypothermia will be determined using generalized linear modeling and reported at specific time points using the R-square statistic. Ease of application, monitoring and nurse satisfaction will be reported using means (standard deviation) or median (interquartile range) in accordance with the underlying distribution of the visual scale. A two sided p-value of 0.05 will be considered to be statistically significant
With 90 subjects, this study will have a 90% power to detect a difference in OMT between any two RASS levels equivalent to 37% of one standard deviation with a two sided p-value of 0.05. Similarly, 90 subjects will provide a 90% power to detect a correlation coefficient at any given time point between OMT and BIS equal to r=0.37 with a two sided p-value of 0.05. These calculations are inclusive of a 15% allowance to account for the unexpected possibility that OMT will not follow a normal distribution19. In accordance with Kevin3, effect sizes of this magnitude are both clinically relevant and biologically achievable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2015
Actual
Date of last participant enrolment
Anticipated
31/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 3947 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 3948 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 9858 0
3168 - Clayton
Recruitment postcode(s) [2] 9859 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 291501 0
Commercial sector/Industry
Name [1] 291501 0
BrainstenBiometrics Prop Ltd
Country [1] 291501 0
United States of America
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 290180 0
None
Name [1] 290180 0
Address [1] 290180 0
Country [1] 290180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293040 0
Prince of Wales Human research and Ethics Committee
Ethics committee address [1] 293040 0
Ethics committee country [1] 293040 0
Australia
Date submitted for ethics approval [1] 293040 0
26/11/2013
Approval date [1] 293040 0
20/12/2013
Ethics approval number [1] 293040 0
HREC/13/POWH/677
Ethics committee name [2] 293041 0
Monash Health Human Research and Ethics Committee
Ethics committee address [2] 293041 0
Ethics committee country [2] 293041 0
Australia
Date submitted for ethics approval [2] 293041 0
11/06/2015
Approval date [2] 293041 0
09/07/2015
Ethics approval number [2] 293041 0
15254A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58190 0
Prof Yahya Shehabi
Address 58190 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 58190 0
Australia
Phone 58190 0
+61 3 9594 2730
Fax 58190 0
+61 3 9594 6063
Email 58190 0
yahya.shehabi@monashhealth.org
Contact person for public queries
Name 58191 0
Yahya Shehabi
Address 58191 0
Program Director Critical Care
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 58191 0
Australia
Phone 58191 0
+61 3 9594 2730
Fax 58191 0
+61 3 9594 6063
Email 58191 0
yahya.shehabi@monashhealth.org
Contact person for scientific queries
Name 58192 0
Yahya Shehabi
Address 58192 0
Program Director Critical Care
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 58192 0
Australia
Phone 58192 0
+61 3 9594 2730
Fax 58192 0
+61 3 9594 6063
Email 58192 0
yahya.shehabi@monashhealth.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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