Actively Recruiting
Implementation of Routine Recording of Intraoperative Adverse Events Using ClassIntra® During the WHO Surgical Safety Checklist Sign-out Phase with a Tailored Implementation Strategy
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-11
1800
Participants Needed
10
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying perioperative patient safety by looking at how recording intraoperative adverse events (iAEs) during surgery can improve outcomes. Adverse events during and after surgery affect up to one third of patients and are a major cause of death worldwide. The study aims to evaluate a multifaceted strategy to improve adherence to the WHO Surgical Safety Checklist and routine recording of iAEs to reduce postoperative complications and improve teamwork in surgery. The study observes two groups of 900 surgical patients each: one before and one after implementing a tailored strategy to enhance surgical safety checklist adherence and iAE documentation. The implementation focuses on standardizing the sign-out phase of surgery using the ClassIntra® system, which classifies intraoperative adverse events. No interventions or treatments are applied as this is an observational study. Participants undergo surgery in various disciplines including general surgery, vascular surgery, orthopedics/traumatology, and urology with anesthesia involvement. Researchers monitor how well the checklist is completed and the quality of its use up to four months after implementation. They also evaluate acceptability, appropriateness, feasibility, and sustainment of the intervention up to 12 months after the last patient is included. The main measure is the completion of checklist components two months after implementation.
CONDITIONS
Brief Title
ClassIntra® for Better Outcomes in Surgery - CIBOSurg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All in-hospital patients undergoing surgery with anesthesia involvement from general surgery, vascular surgery, orthopedics/traumatology, or urology
- Adults aged 18 to 110 years
- Surgery performed in the operating room
- Consecutive or random sample of eligible patients
You will not qualify if you...
- Patients undergoing one-day surgery with or without anesthesia
- Procedures without anesthesia involvement, whether inpatient or outpatient
- Patients classified as ASA VI (brain-death, organ donor)
- Follow-up procedures of patients already included in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months after implementation
Participants who undergo routine surgical care are observed for adherence to the WHO Surgical Safety Checklist and recording of intraoperative adverse events.
During surgery and immediate post-operative period
Duration - Up to 12 months after the last patient completes surgery
Participants are observed to assess sustainment of intervention fidelity and implementation outcomes.
Periodic follow-up visits depending on cohort assignment
Trial Site Locations
Total: 10 locations
1
Radboud UMC
Nijmegen, Netherlands
Withdrawn
2
University Hospital Basel
Basel, Switzerland
Completed
3
Lindenhofspital
Bern, Switzerland
Actively Recruiting
4
University Hospital Berne
Bern, Switzerland
Actively Recruiting
5
Cantonal Hospital Graubünden
Chur, Switzerland
Actively Recruiting
6
University Hospital Geneva
Geneva, Switzerland
Actively Recruiting
7
University Hospital Lausanne
Lausanne, Switzerland
Actively Recruiting
8
Cantonal Hospital Lucerne
Lucerne, Switzerland
Actively Recruiting
9
Regional Hospital Lugano
Lugano, Switzerland
Actively Recruiting
10
University Hospital Zurich
Zurich, Switzerland
Actively Recruiting
Research Team
S
Salome Dell-Kuster, Prof. Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Frequently Asked Questions
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