Plain English Summary
Background and study aims
Cardiac (heart) surgery has become a routine procedure with acceptable risks. However, there is still room for improvement, especially in elderly patients with multiple comorbidities (illnesses). Each of these conditions may require special measures during or shortly after the operation. In these complex situations checklists may help to structure and improve communication between different caregivers. A specific cardiac surgery safety checklist was developed in one hospital (Isala) and then implemented in six other Dutch cardiac centers. This safety checklist focuses on pre-operative known risk factors in combination with a trans-esophageal echo (an ultrasound scan of the heart) that is performed just after induction of anesthesia.
Who can participate?
Adult cardiac surgery patients
What does the study involve?
Participating cardiac centers introduce the safety checklist. The use of the checklist is strongly encouraged but not obligatory. Patients who are operated with the use of the safety checklist are compared with those who are operated without. 30-day and 120-day mortality (death rates), surgical re-exploration, 72-hour stroke and deep sternal wound infections are compared between the groups.
What are the possible benefits and risks of participating?
The benefit of participating is that patient safety may be improved by systematically checking all the possible risk factors for preoperative complications. There is a small risk that the initial operation plan will be adapted. However, these adaptations are meant to increase patient safety and to prevent possible harmful situations.
Where is the study run from?
1. Isala Hospital, Zwolle (Netherlands)
2. Medisch Spectrum Twente (Netherlands)
3. Antonius Hospital Nieuwegein (Netherlands)
4. OLVG (Netherlands)
5. Catharina Hospital (Netherlands)
6. HAGA teaching hospitals (Netherlands)
7. Amphia (Netherlands)
When is the study starting and how long is it expected to run for?
May 2014 to December 2015
Who is funding the study?
Achmea Healthcare (Netherlands)
Who is the main contact?
Mr Alexander Spanjersberg
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Z528-2
Study information
Scientific title
Effects of the implementation of a specific cardiac surgery checklist on mortality in 7 Dutch cardiac centers
Acronym
Study hypothesis
Implementing a specific cardiac surgery safety checklist in multiple cardiac surgery centers results in lower mortality and major complications.
Ethics approval
Committee on Research Ethics of Isala Hospital in Zwolle the Netherlands considered that no further approval was necessary as this is a retrospective study on routine data, 14/08/2014, METC nr 14.08113
Study design
Multicenter observational cohort study during a one-year implementation phase
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Adult cardiac surgery patients
Intervention
Participating centers started to implement the safety checklist from 01/01/2015 and all adult patients undergoing cardiac surgery in one of the participating hospitals were eligible. The use of the checklist was strongly encouraged, but not obligatory. The studied patient population was limited to coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), combination of both, and mitral valve surgery (MVS). Patients who were operated on with the use of the safety checklist were compared with those who were operated without.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
120-day mortality; data retrieved from electronic database of the regional municipal administration
Secondary outcome measures
1. 30-day mortality; data retrieved from electronic database of the regional municipal administration
2. 72-hour stroke; data retrieved from active reporting of participating hospital; stroke is defined as a stroke diagnosed by a neurologist (not TIA), within 72 hours after primary surgery.
3. Surgical re-exploration: data from active reporting; surgical re-exploration is defined as every opening of the thorax after primary closure within 30 days after primary surgery. Causes may be bleeding, tamponade or other, but not mediastinitis
4. Deep sternal wound infection (DSWI); data from active reporting; DSWI is defined as deep sternal wound infection within 30 days after primary surgery
Overall trial start date
27/05/2014
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult cardiac surgery patients
2. Undergoing coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), AVR combined with CABG, and mitral valve surgery (MVS)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The one year study period in 7 Dutch centers will render about 6000 patients undergoing CABG, AVR, AVR+CABG and MVS
Participant exclusion criteria
Data not available on:
1. Type of surgery
2. Use of safety checklist
Recruitment start date
01/01/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
Isala Hospital, Zwolle
Dr van Heesweg 2
Zwolle
8025AB
Netherlands
Trial participating centre
Medisch Spectrum Twente
Koningsplein 1
Enschede
7512 KZ
Netherlands
Trial participating centre
Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
Trial participating centre
OLVG
Oosterpark 9
Amsterdam
1091 AC
Netherlands
Trial participating centre
Catharina Hospital
Michelangelolaan 2
Eindhoven
5623 EJ
Netherlands
Trial participating centre
HAGA teaching hospitals
Els Borst-Eilersplein 275
The Hague
2545 AA
Netherlands
Trial participating centre
Amphia
Molengracht 21
Breda
4818 CK
Netherlands
Sponsor information
Organisation
Achmea Healthcare
Sponsor details
Burgemeester Roelenweg 13
Zwolle
8021 EV
Netherlands
Sponsor type
Other
Website
Organisation
Isala Academy
Sponsor details
Dr Van Heesweg 2
Zwolle
8025 AB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Organisation
Achmea (Netherlands)
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Other
Funder name
Achmea Healthcare
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Main article will be submitted summer 2018. Presentation on ESC congress 2018 Munich.
IPD sharing statement
The dataset will not be directly available, as data ownership is at the participating centers. In the agreement with the participating centers it is stated that data may only be analyzed for the purpose of this study. If there is a request, the participating centers have to be asked for permission to use the data for a new purpose. In the meantime data are held at the national institution: Netherlands Heart Registry.
Intention to publish date
01/08/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list