ClassIntra® for Better Outcomes in Surgery - CIBOSurg

NCT05818332 | Recruiting

• 1 other identifier: Req-2023-00330
• Study Type: observational
• Target: 1,800
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Perioperative Patient Safety

Keywords

Perioperative safety; sign-out; intraoperative adverse events; ClassIntra®; hybrid design

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intervention fidelity - component quality of checklist performance

  Up to four months after the implementation

• Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps

  Up to four months after the implementation

• Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory

  Measured after the implementation

• Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted

  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

  Measured after the implementation

Other Outcomes (9)

• Qualitative conclusions

  Longitudinal data collection before, during and after the implementation

• Characterising themes

  Longitudinal data collection before, during and after the implementation

• Comprehensive Complication Index (CCI®)

  Difference in CCI® before and after the implementation at hospital discharge and at 90 days after surgery

Study Arms (1)

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

Interventions

Observational study OTHER

No intervention, observational only

before and after implementation cohort

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (10)

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

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Salome Dell-Kuster, Prof. Dr. med.

CONTACT

+41 61 328 64 74; salome.dell-kuster@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 18, 2023
• Study Start: July 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

NL (1); CH (9)