Actively Recruiting

Age: 18Years - 110Years
All Genders
ID05818332

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

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

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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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