Improving surgical outcomes with ClassIntra®
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
University Hospital, Basel, Switzerland · NCT05818332
This study is testing if using ClassIntra® can help make surgeries safer by looking at problems that happen before and after surgery in patients across different types of operations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 10 sites (Nijmegen and 9 other locations) |
| Trial ID | NCT05818332 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on enhancing perioperative patient safety by assessing intra- and postoperative adverse events (iAEs and pAEs) in patients undergoing various surgical procedures. It aims to identify the prevalence of these events and their preventability through standardized assessments and teamwork in surgical settings. By analyzing data from patients in general surgery, vascular surgery, orthopaedics, and urology, the study seeks to develop strategies to minimize adverse events and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include in-hospital patients undergoing surgery with anaesthesia involvement across various surgical specialties.
Not a fit: Patients undergoing one-day surgeries or procedures without anaesthesia involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to significant improvements in patient safety and reduced postoperative complications.
How similar studies have performed: Other studies have shown that teamwork and standardized assessments can significantly reduce adverse events in surgical settings, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen and 9 other locations
- Radboud UMC — Nijmegen, Netherlands (WITHDRAWN)
- University Hospital Basel — Basel, Switzerland (COMPLETED)
- Lindenhofspital — Bern, Switzerland (RECRUITING)
- University Hospital Berne — Bern, Switzerland (RECRUITING)
- Cantonal Hospital Graubünden — Chur, Switzerland (RECRUITING)
- University Hospital Geneva — Geneva, Switzerland (RECRUITING)
- University Hospital Lausanne — Lausanne, Switzerland (RECRUITING)
- Cantonal Hospital Lucerne — Lucerne, Switzerland (RECRUITING)
- Regional Hospital Lugano — Lugano, Switzerland (RECRUITING)
- University Hospital Zurich — Zurich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Salome Dell-Kuster, Prof. Dr. med.
- Email: salome.dell-kuster@usb.ch
- Phone: +41 61 328 64 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perioperative Patient Safety, Perioperative safety, sign-out, intraoperative adverse events, ClassIntra®, hybrid design