None listed
Conditions
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.
Interventions
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
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.
Sponsors
Professor Alan Merry
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged over 16 years and who have undergone surgery.
Exclusion criteria
NA
Outcome results
None listed