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Trial registered on ANZCTR


Registration number
ACTRN12610000277044
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
7/04/2010
Date last updated
24/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational, prospective drug administration and physiological data collection during anaesthesia
Scientific title
Real time drug administration and physiological data collection during anaesthesia: observational study to evaluate the validity of current response surface models available in the literature
Secondary ID [1] 1542 0
A+4639
Auckland District Health Board
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Validation of current response surface models (for anaesthetic drug interactions) available in the literature 257032 0
Condition category
Condition code
Anaesthesiology 257189 257189 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective, observational study. We will collect physiological and anaesthetic data prospectively for anaesthetics completed at Auckland City Hospital in the next two years. Electronic anaesthetic records will be collected and physiological data, patient demographics, and any other routinely collected information will be extracted. Data from all physiological monitoring will be directly downloaded during the procedure. Please note: this will not alter standard patient care. Use of all standard and additional monitoring will remain at the discretion of the anaesthetist. In addition, software designed to accurately read and log drug infusion rates from automated Total Intravenous Anaesthesia (TIVA) pumps will collect drug bolus and infusion rate data directly.
Intervention code [1] 256204 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258081 0
The data will be used to evaluate the current response surface models available in the literature, pertaining to drug effect as measured by Bispectral Index Monitoring (BIS). Drug administrations observed in the clinical data will be used as model inputs, and predicted BIS outputs calculated. Predicted BIS will be compared with observed BIS (from the clinical data).
Measures of model performance will include predictive performance (BISobserved - BISpredicted) x 100) , bias and inaccuracy. Diagnostic plots (including predicted and observed effects over time) will also be used to evaluate model performance.
Timepoint [1] 258081 0
Evaluation of models will be performed upon completion of data collection from 160 anaesthetic cases at Auckland City Hospital. We expect this will be fully completed April 2012
Secondary outcome [1] 263677 0
Nil
Timepoint [1] 263677 0
N/A

Eligibility
Key inclusion criteria
Patients receiving general anaesthesia from six demographic groups will be studied:
* Healthy Adults: 18 - 65 years; body mass index 18.5 - 25 (as defined by the World Health Organisation)
* Cardiac bypass patients
* Elderly, defined as age > 70 years
* Overweight, body mass index > 30
* Those who receive total intravenous anaesthesia
* American Society of Anesthesiologists (ASA) grade 3-4 patients undergoing emergency surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with neurological dysfunction, head trauma, opioid dependence and renal or hepatic co-morbidities will not be studied

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2558 0
New Zealand
State/province [1] 2558 0
Auckland

Funding & Sponsors
Funding source category [1] 256706 0
Self funded/Unfunded
Name [1] 256706 0
Address [1] 256706 0
Country [1] 256706 0
Primary sponsor type
University
Name
Department of Anaesthesiology, University of Auckland
Address
Level 12 Support Building
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 255993 0
None
Name [1] 255993 0
Address [1] 255993 0
Country [1] 255993 0
Other collaborator category [1] 1166 0
Hospital
Name [1] 1166 0
Department of Anaesthesia, Auckland City Hospital
Address [1] 1166 0
2 Park Road,
Grafton,
Auckland
1061
Country [1] 1166 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258718 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 258718 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
3204
Ethics committee country [1] 258718 0
New Zealand
Date submitted for ethics approval [1] 258718 0
Approval date [1] 258718 0
04/02/2010
Ethics approval number [1] 258718 0

Summary
Brief summary
Pharmacological models have a variety of applications, including automated drug infusion pumps and human patient simulators. These applications often extrapolate models beyond the datasets in which they were developed, and the uses for which they were designed. As such, models require validation in new datasets to ensure adequate performance. Collection of drug administration and effect data can be used to validate drug dose – effect models. We will prospectively collect data from surgical cases at Auckland City Hospital. This will allow construction of an observational dataset from which current pharmacological models can be validated in our patient population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30979 0
Dr Timothy Short
Address 30979 0
Dept Anaesthesia
Auckland City Hospital
Park Road
Grafton
Auckland
1023
Country 30979 0
New Zealand
Phone 30979 0
+643737599 ext 98308
Fax 30979 0
Email 30979 0
TimS@adhb.govt.nz
Contact person for public queries
Name 14226 0
Miss Jacqueline Amy Hannam
Address 14226 0
Dept of Anaesthesiology
University of Auckland
2 Park Road
Grafton
Auckland
1023
Country 14226 0
New Zealand
Phone 14226 0
+64 9 3737 599 ext 89300
Fax 14226 0
Email 14226 0
j.hannam@auckland.ac.nz
Contact person for scientific queries
Name 5154 0
Miss Jacqueline Amy Hannam
Address 5154 0
Dept of Anaesthesiology
University of Auckland
2 Park Road
Grafton
Auckland
1023
Country 5154 0
New Zealand
Phone 5154 0
+64 9 3737 599 ext 89300
Fax 5154 0
Email 5154 0
j.hannam@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary