Effects of the implementation of a specific Safety Checklist in cardiac surgery
| ISRCTN | ISRCTN16953845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16953845 |
| Secondary identifying numbers | Z528-2 |
- Submission date
- 12/06/2018
- Registration date
- 14/06/2018
- Last edited
- 14/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Dr van Heesweg 2
Zwolle
8025AB
Netherlands
Study information
| Study design | Multicenter observational cohort study during a one-year implementation phase |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of the implementation of a specific cardiac surgery checklist on mortality in 7 Dutch cardiac centers |
| Study objectives | Implementing a specific cardiac surgery safety checklist in multiple cardiac surgery centers results in lower mortality and major complications. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 27/05/2014 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| Key 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) |
| Key exclusion criteria | Data not available on: 1. Type of surgery 2. Use of safety checklist |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Zwolle
8025AB
Netherlands
Enschede
7512 KZ
Netherlands
Nieuwegein
3435 CM
Netherlands
Amsterdam
1091 AC
Netherlands
Eindhoven
5623 EJ
Netherlands
The Hague
2545 AA
Netherlands
Breda
4818 CK
Netherlands
Sponsor information
Other
Burgemeester Roelenweg 13
Zwolle
8021 EV
Netherlands
| Website | achmea.nl |
|---|
Hospital/treatment centre
Dr Van Heesweg 2
Zwolle
8025 AB
Netherlands
| Website | www.isala.nl/academie |
|---|
Not defined
| Website | https://www.achmea.nl/ |
|---|---|
"ROR" |
https://ror.org/00gqmky69 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Main article will be submitted summer 2018. Presentation on ESC congress 2018 Munich. |
| IPD sharing plan | 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. |
