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Trial registered on ANZCTR


Registration number
ACTRN12611000406909
Ethics application status
Approved
Date submitted
28/03/2011
Date registered
19/04/2011
Date last updated
23/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of the “WHO Surgical Safety Checklist” to reduce postoperative morbidity and mortality
Scientific title
Validation of the “WHO Surgical Safety Checklist” to reduce postoperative morbidity and mortality following surgical procedures - A retrospective, pre and post intervention cohort study of mortality and morbity outcomes
Secondary ID [1] 259869 0
nil
Universal Trial Number (UTN)
U1111-1120-3041
Trial acronym
CheckWHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mortality and morbidity outcomes 265457 0
Condition category
Condition code
Anaesthesiology 265609 265609 0 0
Other anaesthesiology
Surgery 265614 265614 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1) This is a RETROSPECTIVE audit comparing outcome data between two cohorts of patients before and after the implementation of a checklist. The checklist is now part of normal clinical practise and completed by the members of the anaesthesia, nursing and surgical team in every operation in the operating room. This study is comparing the outcome data between two periods as described in (3) below.
2) Elements of the Surgical Safety Checklist
Sign in
Before induction of anaesthesia, members of the team (at least the nurse and an anaesthesia professional) orally confirm that:
i) The patient has verified his or her identity, the surgical site and procedure, and consent
ii) The surgical site is marked or site marking is not applicable
iii) The pulse oximeter is on the patient and functioning
iv) All members of the team are aware of whether the patient has a known allergy
v) The patient’s airway and risk of aspiration have been evaluated and appropriate equipment and assistance are available
vi) If there is a risk of blood loss of at least 500 ml (or 7 ml/kg of body weight, in children), appropriate access and fluids are available
Time out
Before skin incision, the entire team (nurses, surgeons, anaesthesia professionals, and any others participating in the care of the patient) orally:
i) Confirms that all team members have been introduced by name and role
ii) Confirms the patient’s identity, surgical site, and procedure
iii) Reviews the anticipated critical events
iv) Surgeon reviews critical and unexpected steps, operative duration, and anticipated blood loss
v) Anaesthesia staff review concerns specific to the patient
vi) Nursing staff review confirmation of sterility, equipment availability, and other concerns
vii) Confirms that prophylactic antibiotics have been administered 60 min before incision is made or that antibiotics are not indicated
viii) Confirms that all essential imaging results for the correct patient are displayed in the operating room
Sign out
Before the patient leaves the operating room:
i) Nurse reviews items aloud with the team
ii) Name of the procedure as recorded
iii) That the needle, sponge, and instrument counts are complete (or not applicable)
iv) That the specimen (if any) is correctly labelled, including with the patient’s name
v) Whether there are any issues with equipment to be addressed
vi) The surgeon, nurse, and anaesthesia professional review aloud the key concerns for the recovery and care of the patient

3) Study periods:
For the present study, data will be collected from patient records in two periods:
Period 1 (pre-check list): the 18-month period from 1 May 2006 to 31 October 2007
Period 2 (post-check list): the 18-month period from 1 May 2009 to 31 October 2010.
Intervention code [1] 264291 0
Not applicable
Comparator / control treatment
Pre Checklist cohort - 1500 randomly chosen patients in the 18-month period from 1 May 2006 to 31 October 2007

For clarificaton, patients DO NOT fill in the checklist. The control period (described above) was before the implementation of the checklist.

This is a RETROSPECTIVE audit comparing outcome data between two cohorts of patients before and after the implementation of a checklist. The checklist is now part of normal clinical practise and completed by the members of the anaesthesia, nursing and surgical team in every operation in the operating room.
Control group
Historical

Outcomes
Primary outcome [1] 302684 0
Days alive and out of hospital (DAOH) is a patient-centred composite measure more commonly used in the cardiology literature. It reflects any major complications, including death.

A patient's DAOH is the number of days after surgery, up to a predefined limit, that the patient was both alive, and was not admitted to hospital. The DAOH limit for this study will be 90 days, thus each participant can receive a maximum DAOH of 89 (all participants underwent surgery on the first day), and a minimum of zero.
Timepoint [1] 302684 0
Update Data will be collected from patient records in two periods: Period 1 (pre-check list): the 18-month period from 1 May 2006 to 31 October 2007 Period 2 (post-check list): the 18-month period from 1 May 2009 to 31 October 2010.
Secondary outcome [1] 273696 0
Our secondary hypothesis, stated as a null hypothesis, is that there will be no difference between Maori and all other ethnic groups combined in the primary end-point. Therefore our second outcome measure is the rate of mortality and morbidity (as defined above) measured between Maori and non Maori.
Timepoint [1] 273696 0
Data will be collected from patient records in two periods:

Period 1 (pre-check list): the 18-month period from 1 May 2006 to 31 October 2007
Period 2 (post-check list): the 18-month period from 1 May 2009 to 31 October 2010.

Eligibility
Key inclusion criteria
Patients aged over 16 years and who have undergone surgery.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NA

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2011
Actual
14/03/2011
Date of last participant enrolment
Anticipated
Actual
30/04/2017
Date of last data collection
Anticipated
Actual
30/04/2017
Sample size
Target
3000
Accrual to date
Final
22000
Recruitment outside Australia
Country [1] 3294 0
New Zealand
State/province [1] 3294 0
Auckland

Funding & Sponsors
Funding source category [1] 264746 0
Charities/Societies/Foundations
Name [1] 264746 0
Australian and New Zealand College of Anaesthetists
Country [1] 264746 0
Australia
Primary sponsor type
Individual
Name
Professor Alan Merry
Address
Department of Anaesthesiology
University of Auckland
Private Bag 92 019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 263871 0
Individual
Name [1] 263871 0
Associate Professor Simon John Mitchell
Address [1] 263871 0
Department of Anaesthesiology
University of Auckland
Private Bag 92 019
Auckland 1142
Country [1] 263871 0
New Zealand
Secondary sponsor category [2] 263872 0
Individual
Name [2] 263872 0
Associate Professor Papaarangi Reid
Address [2] 263872 0
Department of Anaesthesiology
University of Auckland
Private Bag 92 019
Auckland 1142
Country [2] 263872 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266862 0
Northern X Regional Ethics Committee
Ethics committee address [1] 266862 0
Private Bag 92544
Wellesley Street
Auckland 1141
Ethics committee country [1] 266862 0
New Zealand
Date submitted for ethics approval [1] 266862 0
Approval date [1] 266862 0
11/03/2011
Ethics approval number [1] 266862 0

Summary
Brief summary
Our aim is to confirm (or refute) the benefits to New Zealand patients of the introduction of the Surgical Safety Checklist developed by the Safe Surgery Saves Lives Initiative of the World Health Organisation (WHO) as demonstrated in a previous international study (the “WHO Study”).

Our hypothesis is that the introduction of the Checklist will have improved outcomes in New Zealand patients undergoing surgery. The primary outcome will be all predefined complications, including mortality.

The significance of this work is that it has the potential to validate the efficacy of the Surgical Safety Checklist in a locally representative patient population, thus endorsing its use in preventing surgical iatrogenic harm in New Zealand and Australia.

Methods:
We will collect data describing outcomes for cohorts of adult patients from the years 2006-2007 (pre-checklist) and 2009-2010 (post-checklist) from existing Auckland City Hospital databases and electronic patient records on the rates of the complications, including mortality, specified in the WHO Study, using the same definitions of the American College of Surgeons’ National Surgical Improvement Program. In-hospital complications occurring within 30 days of surgery will be included. Secondary outcomes of the detection and description of possible ethnic disparities in patient outcome and the quality of patient records will also be collected for the period of the study. We will also calculate days alive and out of hospital (DAOH) for each participant in the 90 days following surgery.

Study Periods:

In the previous study, data were collected from patients between 27th November 2007 and 23rd January 2008. For the present study, data will be collected from patient records in two periods:

Period 1 (pre-check list): the 18-month period from 1 May 2006 to 31 October 2007
Period 2 (post-check list): the 18-month period from 1 May 2009 to 31 October 2010.

Number of Participants:
For the mortality endpoint, all patients in Period 1 will be compared with those in Period 2 – this being possible because mortality data can be obtained by more automated means than the complications data. On the basis of previous patient volumes this would be expected to be approximately 11,000 patients in each period.

For complications other than mortality, 1,500 records will be randomly selected from a master list of all adult patients in Period 1 and reviewed for complications. The results will be compared with 1,500 similarly randomly selected and reviewed patient records from Period 2.

Main Criteria for Inclusion:
Adult patients undergoing surgery in the level 8 operating theatre suite treated at Auckland City Hospital during the study periods. This includes all surgical disciplines except cardiothoracic, ear nose and throat, and obstetrics and gynaecology. This is comparable with the population studied previously.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32315 0
Prof Alan Merry
Address 32315 0
Department of Anaesthesiology University of Auckland Private Bag 92 019 Auckland 1142
Country 32315 0
New Zealand
Phone 32315 0
+64 9 373 7599 ext 89300
Fax 32315 0
Email 32315 0
[email protected]
Contact person for public queries
Name 15562 0
Professor Alan Merry
Address 15562 0
Department of Anaesthesiology
University of Auckland
Private Bag 92 019
Auckland 1142
Country 15562 0
New Zealand
Phone 15562 0
+64 9 373 7599 ext 89300
Fax 15562 0
Email 15562 0
[email protected]
Contact person for scientific queries
Name 6490 0
Professor Alan Merry
Address 6490 0
Department of Anaesthesiology
University of Auckland
Private Bag 92 019
Auckland 1142
Country 6490 0
New Zealand
Phone 6490 0
+64 9 373 7599 ext 89300
Fax 6490 0
Email 6490 0
[email protected]

No information has been provided regarding IPD availability


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.