Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000068369
Ethics application status
Approved
Date submitted
6/02/2008
Date registered
7/02/2008
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Date results information initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimodal, clinical assessment of a system to reduce error during anaesthesia.
Scientific title
Comparison of SaferSleep Integrated Drug Administration System (and its components) with standard clinical practice in clinical anaesthesia
Secondary ID [1] 299830 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Integrated Drug Administration System (IDAS) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug administration error and failures in vigilance in anaesthesia 2794 0
Condition category
Condition code
Anaesthesiology 2929 2929 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multimodal integrated system for the safe administration of drugs and compilation of an accurate automated record during anaesthesia
This System has now been used in 170,000 anaesthetics. It is multifaceted and includes novel equipment, consumables and procedures. It was designed on the basis of lessons from empirical incident reporting, the psychological mechanisms underlying human error and the principles of system safety developed in the high-risk chemical, nuclear and aviation industries. It includes specialised trays (which support aseptic technique and promote a well-organised anaesthetic workspace), colour- and bar-coded labelling of syringes (which facilitate the selection and tracking of drugs), pre-filled syringes for the most commonly used anaesthetic drugs (to remove a key error-prone step in drug administration and to save time), and automatic visual and auditory verification of syringes using a computer and bar-codes just prior to each drug administration. The System also compiles an automated anaesthetic record, with the intention of improving comprehensiveness and accuracy, and of freeing the anaesthetist to spend more time caring for and monitoring the patient.
The duration of the intervention will be up to 12 months in one or more designated operating rooms at Auckland City Hospital
Intervention code [1] 2534 0
Other interventions
Comparator / control treatment
Standard clinical practice with a conventional handwritten record
Control group
Active

Outcomes
Primary outcome [1] 3810 0
The composite of 1) rates of error related to iv drug administration; 2) failures in the accuracy and completeness of the anaesthetic iv drug records
Timepoint [1] 3810 0
The rates of drug administration errror will be assessed by obesrvaton and other techniques during each anaesthetic, over a period of up to 12 months in one or more designated operating rooms. Failures in the accuracy and completeness of anaesthetic records will be assessed weekly by reference to copies of the records.
Primary outcome [2] 3811 0
Failures in the accuracy and completeness of anaesthetic records
Timepoint [2] 3811 0
Assessed after each anaesthetic
Primary outcome [3] 240764 0
Lapses in vigilance tested with a vigilance
probe. To be reported as a co-primary outcome with outcome 1.
Timepoint [3] 240764 0
Lapses in vigilance will be assssed in real time using an automated vigilance probe during the study anaesthetics.
Secondary outcome [1] 6423 0
The difference between Maori and other groups of patients combined in the primary outcome variable
Timepoint [1] 6423 0
Ethnic data will be collected for all participating patients at the start of each anaesthetic
Secondary outcome [2] 6424 0
Rate of actual harm from error
Timepoint [2] 6424 0
At discharge from hospital
Secondary outcome [3] 6425 0
Evaluation of safety assessment code (SAC) for each error ? see below
Timepoint [3] 6425 0
At discharge from hospital
Secondary outcome [4] 6426 0
Quantitative and qualitative measures of workflow
Timepoint [4] 6426 0
Assessed in real time by observation during each anaesthetic
Secondary outcome [5] 6427 0
Legibility of records
Timepoint [5] 6427 0
Assessed at the end of each anaesthetic
Secondary outcome [6] 6428 0
Cost of procedures (in terms of money and time)
Timepoint [6] 6428 0
Calculated after each anaesthetic

Eligibility
Key inclusion criteria
All patients undergoing anaesthesia in designated operating rooms in Auckland City Hospital during the study period.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
THose who do not wish to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Weeks will be randomised to compare intervention with control, using computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2008
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
28/02/2009
Date of last data collection
Anticipated
Actual
28/02/2009
Sample size
Target
1000
Accrual to date
Final
1075
Recruitment outside Australia
Country [1] 779 0
New Zealand
State/province [1] 779 0
Northern

Funding & Sponsors
Funding source category [1] 3055 0
Government body
Name [1] 3055 0
Health Research Council
Country [1] 3055 0
New Zealand
Primary sponsor type
Individual
Name
Professor Alan Merry
Address
Head of Department, Anaesthesiology,
University of Auckland,
Private Bag 92019,
98-100 Mountain Rd
Epsom
Auckland
Country
New Zealand
Secondary sponsor category [1] 2753 0
Government body
Name [1] 2753 0
Health Research Council
Address [1] 2753 0
PO Box 5541
Wellesly St
Level 3, 110 Stanley St
Auckland
Auckland
Country [1] 2753 0
New Zealand
Other collaborator category [1] 198 0
Other Collaborative groups
Name [1] 198 0
National Patient Safety Agency
Address [1] 198 0
4-8 Maple Street,

London
Country [1] 198 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5007 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5007 0
PO Box 1031
Hamilton
Ethics committee country [1] 5007 0
New Zealand
Date submitted for ethics approval [1] 5007 0
Approval date [1] 5007 0
29/11/2007
Ethics approval number [1] 5007 0
NTY/07/10/112

Summary
Brief summary
Preventable harm in healthcare is a major public-health problem throughout the world with high human and financial costs. We have previously developed a set of innovations designed to improve safety during anaesthesia, and propose an in-depth evaluation of these in comparison with conventional methods. This evaluation will use established formal methods and be based on six-months of observation in two operating theatres at Auckland City Hospital. We have interest for separately funded identical projects in North America, the UK, and the Netherlands, but the New Zealand (NZ) site is powered to stand alone. This project will increase knowledge of how to improve patient safety, including an evaluation of ethnic disparity as a possible factor in anaesthesia safety. It has the potential to reduce harm (including death) to patients during anaesthesia, and to save money (because harm necessitates further costly treatment). Such outcomes would benefit patients in NZ and overseas.
Trial website
Trial related presentations / publications
Merry AF, Webster CS, Hannam J, Mitchell SJ, Henderson R, Reid P, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011;343:d5543.
(30/09/2013)
Public notes

Contacts
Principal investigator
Name 28352 0
Prof Alan Merry
Address 28352 0
Department of Anaesthesiology,
The University of Auckland,
Private Bag 92019,
Auckland 1142
Country 28352 0
New Zealand
Phone 28352 0
+6421492297
Fax 28352 0
+6493737970
Email 28352 0
[email protected]
Contact person for public queries
Name 11509 0
Prof Professor Alan Merry
Address 11509 0
Head of Department, Anaesthesiology,
University of Auckland,
Private Bag 92019,
Auckland
Country 11509 0
New Zealand
Phone 11509 0
+6493737599 89300
Fax 11509 0
+64 9 3737970
Email 11509 0
[email protected]
Contact person for scientific queries
Name 2437 0
Prof Professor Alan Merry
Address 2437 0
Head of Department, Anaesthesiology,
University of Auckland,
Private Bag 92019,
Country 2437 0
New Zealand
Phone 2437 0
+6493737599 89300
Fax 2437 0
+64 9 3737970
Email 2437 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.