Pilot study to assess an evidence-based anaesthesia monitoring system

A pilot study in patients undergoing anaesthesia for major surgery who will be monitored using an additional computer based system (EBMi); whether the EBMi system has any advantages over conventional monitoring will be assessed by the anaesthetist in charge of the patients care.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000144718

Enrollment

Registered

2013-02-06

Start date

2013-04-01

Completion date

Unknown

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 anaesthesia monitors we now use have not changed significantly over the last 25 years. We are still presented with simple trend displays of various parameters over time, digital values that are updated every 10s and waveforms of some variables. There is virtually no interpretation of these variables and it is very easy to miss significant changes that take place slowly over time. The Evidence-Based monitor software follows trend in key variables and detects patterns of changes in these variable that are associated with 'organised' physiological responses and alerts the anaesthetist to the possibility of an adverse state. This software has been tested off-line on two patient databases (both had ethical approval for data collection) but has never been tested in real-time in an operating theatre. Objectives 1. To show that the software will run continuously without breakdowns 2. To assess its ease of use 3. To assess its usefulness a) Did it highlight events that may have been missed because of other factors b) Did it stimulate a change in patient management. 4. To determine the correctness of the advice a) Did it suggest diagnoses that were incorrect (False positives) b) Did it fail to suggest a diagnosis when the clinician expected a response (False negative) c) Did it 'keep quiet' when nothing was happening (True negatives) d) Did it correctly diagnose adverse events for which it is designed (True positive)

Interventions

Use of novel software to augment present anaesthesia monitoring. The software includes the ability to detect / diagnose various adverse events during anaesthesia...including hypovolaemia, age and disease related hypotension, Cushing response, sympathetic response, low anaesthetic concentration, damped arterial trace. The alerts are presented visually and audibly in plain English. The software will run for the duration of the anaesthetic .

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Healthy volunteers

Inclusion criteria

Adult - aged over 16 years Able to give consent Major surgery involving the use of intra-arterial monitoring

Exclusion criteria

Younger than 16 years of age

Outcome results