ClassIntra® for Better Outcomes in Surgery - CIBOSurg (CIBOSurg)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Patient Safety
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: Name: Salome Dell-Kuster, Prof. Dr. med.; Phone Number: +41 61 328 64 74; Email: salome.dell-kuster@usb.ch

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Withdrawn
    • Radboud UMC
• Switzerland
  • Basel, Switzerland
    • Completed
    • University Hospital Basel
  • Bern, Switzerland
    • Recruiting
    • University Hospital Berne
    • Contact: Andreas Vogt, Prof. Dr. med.; Phone Number: +41 31 632 42 17; Email: andreas.vogt@insel.ch
  • Berne, Switzerland
    • Recruiting
    • Lindenhofspital
    • Contact: Judith Winkens; Phone Number: +41 31 366 39 89; Email: judith.winkens@lindenhofgruppe.ch
  • Chur, Switzerland
    • Recruiting
    • Cantonal Hospital Graubünden
    • Contact: Gianluca Ursprung, Dipl. med.; Phone Number: +41 81 256 69 32; Email: gianluca.ursprung@ksgr.ch
  • Geneva, Switzerland
    • Recruiting
    • University Hospital Geneva
    • Contact: Guy Haller, Prof. Dr. med.; Email: guy.haller@huge.ch
  • Lausanne, Switzerland
    • Recruiting
    • University Hospital Lausanne
    • Contact: Dieter Hahnloser, Prof. Dr. med.; Phone Number: +41 21 314 66 31; Email: dieter.hahnloser@chuv.ch
  • Lucerne, Switzerland
    • Recruiting
    • Cantonal Hospital Lucerne
    • Contact: Markus Gass, Dr. med.; Phone Number: +41 41 205 45 39; Email: markus.gass@luks.ch
  • Lugano, Switzerland
    • Recruiting
    • Regional Hospital Lugano
    • Contact: Giorgio Prouse, Dr. med.; Phone Number: +41 91 811 66 03; Email: Giorgio.Prouse@eoc.ch
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Valentin Neuhaus, Prof. Dr. med.; Phone Number: +41 44 255 23 99; Email: valentin.neuhaus@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
before and after implementation cohort; consecutive cohort of 900 surgical patients (baseline) consecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs)	Other: Observational study; No intervention, observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention fidelity - component checklist completion	Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.	2 months after the end of the implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention fidelity - component quality of checklist performance	Quality of the sign-out will be measured with the WHO behaviourally anchored rating scale (WHOBARS): Quality will be measured in a random sample of 20-25%, assessed in those centres with well-established sign-out in the baseline period and in all centres in the after-implementation phase.	Up to four months after the implementation
Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps	Quantitative and qualitative evaluation of critical implementation steps followed or not (and why not) by each site, according to the proposed/designed implementation plan (template)	Up to four months after the implementation
Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory	Acceptability is the extent of perception among stakeholders that the intervention is agreeable or satisfactory. It will be measured according to the Acceptability of Intervention Measure (AIM).	Measured after the implementation
Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted	Adaptation is the extent to which sign-out and documentation of iAEs have been locally adapted. It will be measured by comparing the local checklists with the minimum standard sign-out.	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	Appropriateness is the extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting. It will be measured by the Intervention Appropriateness Measure (IAM).	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	Feasibility is the extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting. It will be measured by the Feasibility of Intervention Measure FIM.	Measured after the implementation
Sustainment	Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation	12 months after the last patient out

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative conclusions	Qualitative conclusions about the effectiveness of the employed implementation strategy.	Longitudinal data collection before, during and after the implementation
Characterising themes	Themes characterising the factors that influenced the observed implementation processes, based on the results from the contextual analysis.	Longitudinal data collection before, during and after the implementation
Comprehensive Complication Index (CCI®)	CCI® (Comprehensive Complication Index) is the weighted sum of all pAEs according to Clavien-Dindo. It will be assessed at hospital discharge and at 90 days after surgery.	Difference in CCI® before and after the implementation at hospital discharge and at 90 days after surgery
Severe iAEs according to ClassIntra®	Severe iAEs according to ClassIntra® are defined as greater than or equal to grade III.	Difference in number of severe iAEs before and after the implementation
Total number of iAEs according to ClassIntra®	Total number of iAEs according to ClassIntra® occurring in the baseline and the after implementation period.	Difference in total number of iAEs before and after the implementation
Severe pAEs according to Clavien-Dindo	Severe pAEs according to Clavien-Dindo are defined as greater than or equal to grade IIIa. They will be assessed at hospital discharge and at 90 days after surgery.	Difference in number of severe iAEs before and after the implementation
Total number of pAEs according to Clavien-Dindo	Total number of pAEs according to Clavien-Dindo occurred in the baseline and the after implementation period. They will be assessed at hospital discharge and at 90 days after surgery.	Difference in total number of pAEs before and after the implementation
Number of resulting actions due to the routine recording and discussion of iAEs during the sign-out	Resulting actions are e.g. preventive measures for anticipated pAEs.	Difference in number of resulting actions before and after the implementation
Length of hospital stay	Length of hospital stay will be measured in days.	Difference in length of hospital stay before and after the implementation

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sign-out; hybrid design; intraoperative adverse events; Perioperative safety; ClassIntra®
• Other Study ID Numbers: Req-2023-00330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No