ClassIntra® for Better Outcomes in Surgery - CIBOSurg
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study.
- Who it may be relevant to
- Registry conditions: Perioperative Patient Safety. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementation of Routine Recording of Intraoperative Adverse Events According to ClassIntra® During the Sign-out Phase of the WHO Surgical Safety Checklist Using a Multifaceted, Tailored Implementation Strategy: Protocol of a Collaborative Before- and After-cohort Project
Overview
Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.
Interventions
- Other Observational study
No intervention, observational only
Primary outcome measures
- Intervention fidelity - component checklist completion [Time frame: 2 months after the end of the implementation]
Secondary outcome measures (7)
- Intervention fidelity - component quality of checklist performance [Time frame: Up to four months after the implementation]
- Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps [Time frame: Up to four months after the implementation]
- Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory [Time frame: Measured after the implementation]
- Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted [Time frame: Checklist and process modifications classified according to FRAME.]
- Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting [Time frame: Measured after the implementation]
- Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting [Time frame: Measured after the implementation]
- Sustainment [Time frame: 12 months after the last patient out]
Eligibility criteria
Inclusion criteria
\- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement
Exclusion criteria
- Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
- Procedures without anaesthesia-involvement (in- or out-patient)
- ASA risk classification (ASA) VI patients (brain-death, organ-donor)
- Follow-up procedure of a patient already included in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 9 centers
- University Hospital Basel — Basel
- Lindenhofspital — Bern
- University Hospital Berne — Bern
- Cantonal Hospital Graubünden — Chur
- University Hospital Geneva — Geneva
- University Hospital Lausanne — Lausanne
- Cantonal Hospital Lucerne — Lucerne
- Regional Hospital Lugano — Lugano
- … and 1 more center
Netherlands · 1 center
- Radboud UMC — Nijmegen
Identifiers
NCT: NCT05818332 · Req-2023-00330