Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000125729
Ethics application status
Approved
Date submitted
1/12/2021
Date registered
27/01/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of methods to detect awareness under anaesthesia for patients undergoing electro-convulsive therapy.
Scientific title
The use of Bispectral index (BIS) in comparison to limb-isolation technique to predict awareness in Electro-Convulsive Therapy (ECT): A pilot study
Secondary ID [1] 305882 0
Nil Known
Universal Trial Number (UTN)
U1111-1271-9463
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Awareness under anaesthesia 324487 0
Depression 324831 0
Condition category
Condition code
Anaesthesiology 321972 321972 0 0
Anaesthetics
Mental Health 321973 321973 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For ECT, it is common practice to use as a low an anaesthetic dose as practical as the anaesthetic induction drugs have a tendency to suppress the therapeutic ECT seizure. This leads to an increased risk of awareness under anaesthesia. Despite this increased risk, many institutions take no extra precautions. Others, such as our institution, use an isolated limb technique, where the patient's foot is isolated from the paralysing drugs with a BP cuff so if the patient is still awake they can still communicate by moving their foot, prior to treatment. The use of Bispectral index (BIS) (EEG brain monitoring to prevent awareness under anaesthesia is in common use in other areas of anaesthesia) has been described for ECT but there are no papers comparing BIS and isolated limb technique or their comparative accuracy. Our exposure will be to add a BIS monitoring to our standard isolated limb technique, and have an independent observer record the value on the BIS monitor and the presence or absence of foot movement to voice command just prior to the ECT treatment.

ECT procedures typically take 20-30 mins from when the patient wheels into operating theatre to wheels out. The actual anaesthetic and ECT treatment take around 10-15 mins, with the rest of the time need for setup. This trial is not expected to increase the time per procedure as the BIS electrodes can be attached by the anaesthetist in parallel with the psychiatrist attaching the ECT electrodes.

It is anticipated the majority of patients enrolled in the trial will have a single treatment observed but some may have more than one treatment session observed, the frequency of which is determined by whatever their normal treatment schedule is. For example, some patients receive fortnightly or monthly maintenance ECT, in which case they would be observed fortnightly, or monthly. Some patients receive higher frequency, for example ECT every second day. The trial does not determine in anyway how often the patient receives ECT, it only observes them during their normal treatment. The observation will be performed members of the trial team, either Dr Mackenzie, or Dr Allysan Armstrong-Brown, (both trained in Anaesthesia) who will be in the operating theatre observing. In addition, the patient will have their own treating Anaesthetist who is blinded to the BIS scores, and will be looking after their ECT patient as they normally would.
Intervention code [1] 322545 0
Diagnosis / Prognosis
Comparator / control treatment
The gold-standard is the isolated-limb technique. The BIS will be compared against the isolated-limb technique.
Control group
Active

Outcomes
Primary outcome [1] 329759 0
Proportion of patients that move their isolated limb to command. An independent monitor will prospectively record movement of isolated limb immediately before treatment.
Timepoint [1] 329759 0
2 minutes post induction of anaesthesia just prior to ECT stimulus
Primary outcome [2] 329760 0
Proportion of patients with BIS scores less than 60. An independent monitor will prospectively record the BIS score immediately before treatment. (The treating anaesthetist will be blinded to the BIS score).
Timepoint [2] 329760 0
2 minutes post induction of anaesthesia just prior to ECT stimulus
Secondary outcome [1] 403673 0
Nil
Timepoint [1] 403673 0
Nil

Eligibility
Key inclusion criteria
Individuals having voluntary ECT at Calvary Mater Hospital Newcastle
Individuals having ECT for major depressive disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Indication for ECT other than major depressive disorder, including schizophrenia, schizoaffective disorder, bipolar disorder, catatonia, active psychosis
Treatment with anti-epileptic medication

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The underlying rate of a patient awareness using the isolated limb technique for ECT patients is unknown so this trial is a pilot study to determine the rates of movement of isolated limb and also BIS scores in ECT patients so that the statistics for determining the power required for a subsequent larger study can be accurately determined. The two diagnostic techniques accuracy will be compared using Kappa.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
50
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21247 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 36120 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 310229 0
Hospital
Name [1] 310229 0
Calvary Mater Newcastle
Country [1] 310229 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 311327 0
Individual
Name [1] 311327 0
Dr Allysan Armstrong-Brown
Address [1] 311327 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country [1] 311327 0
Australia
Secondary sponsor category [2] 311387 0
Individual
Name [2] 311387 0
Dr Hamish Meares
Address [2] 311387 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country [2] 311387 0
Australia
Secondary sponsor category [3] 311389 0
Individual
Name [3] 311389 0
Dr Laura Mackenzie
Address [3] 311389 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country [3] 311389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309913 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309913 0
Ethics committee country [1] 309913 0
Australia
Date submitted for ethics approval [1] 309913 0
15/09/2021
Approval date [1] 309913 0
11/10/2021
Ethics approval number [1] 309913 0
2021/ETH00928

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

Contacts
Principal investigator
Name 115810 0
Dr Laura Mackenzie
Address 115810 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country 115810 0
Australia
Phone 115810 0
+61 2 4985 0537
Fax 115810 0
+61 2 4014 3303
Email 115810 0
Laura.Mackenzie@health.nsw.gov.au
Contact person for public queries
Name 115811 0
Laura Mackenzie
Address 115811 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country 115811 0
Australia
Phone 115811 0
+61 2 4985 0537
Fax 115811 0
+61 2 4014 3303
Email 115811 0
Laura.Mackenzie@health.nsw.gov.au
Contact person for scientific queries
Name 115812 0
Laura Mackenzie
Address 115812 0
Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St,
Waratah NSW 2298
Country 115812 0
Australia
Phone 115812 0
+61 2 4985 0537
Fax 115812 0
+61 2 4014 3303
Email 115812 0
Laura.Mackenzie@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw line-by-line data collected from each participant
Data dictionaries
When will data be available (start and end dates)?
From conclusion of study estimated to be around 20th July 2022, and will be available for 20 years from that date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
Dr Laura Mackenzie
c/o Anaesthetic Department
Calvary Mater Newcastle
Edith &, Platt St, Waratah
NSW 2298
+ 61 2 4985 0537
Laura.Mackenzie@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14296Study protocol    383188-(Uploaded-05-01-2022-15-47-27)-Study-related document.docx
14594Informed consent form    383188-(Uploaded-05-01-2022-15-50-54)-Study-related document.docx
14595Ethical approval    383188-(Uploaded-05-01-2022-15-52-01)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.