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Peri-Operative Evaluation of Sedation Depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT)

Peri-Operative Evaluation of Sedation Depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT) in comparison with clinically used tools.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000846527
Enrollment
90
Registered
2015-08-14
Start date
2015-08-31
Completion date
2016-08-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to assess monitoring of anaesthetised and sedated patients in intensive care using devices that assess different parts of your brain activity which reflects your level of consciousness and sedation. Sedation management is based on a wide range of factors including variable assessments of amnesia and recall, comfort level, risk of self-injury, and nurses’ judgment. At present the standardised sedation scoring systems such as the Richmond Agitation Scoring Scale (RASS) and the Glasgow Coma Score (GCS) are used frequently by doctors and nurses to manage sedative medication to ensure patient comfort. Monitoring device such as the Bispectral Index (BIS), which measures electrical activity of the brain via small external pads attached to the forehead, is used in patients undergoing general anaesthesia fairly routinely. Comparison of these three different sedation monitoring techniques with the different combinations of standardly used anaesthetics and analgesics will hopefully determine more accurate ways of tracking patient’s sedation levels and improve management in both surgery and intensive care settings. Furthermore, as light sedation is highly desirable in intensive care patients, this study will test the feasibility of using OMT in achieving light sedation more effectively than with clinical scales.

Interventions

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 stand

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.

Sponsors

Monash Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective/semi-elective cardiac surgery and expected to be ventilated and sedated post-operatively.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026