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NCT Number: NCT05818332

ClassIntra® for Better Outcomes in Surgery - CIBOSurg

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.

Recruiting

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Key information

Conditions

Perioperative Patient Safety

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud UMC, Nijmegen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

No intervention, observational only

Primary outcomes

  1. Intervention fidelity - component checklist completion

    Time frame: 2 months after the end of the implementation

    Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.

Secondary outcomes

  1. Intervention fidelity - component quality of checklist performance

    Time frame: Up to four months after the implementation

    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.

  2. Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps

    Time frame: Up to four months after the implementation

    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)

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

    Time frame: Measured after the implementation

    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).

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

    Time frame: Checklist and process modifications classified according to FRAME.

    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.

  5. Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting

    Time frame: Measured after the implementation

    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).

  6. Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting

    Time frame: Measured after the implementation

    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.

  7. Sustainment

    Time frame: 12 months after the last patient out

    Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation

Other outcomes

  1. Qualitative conclusions

    Time frame: Longitudinal data collection before, during and after the implementation

    Qualitative conclusions about the effectiveness of the employed implementation strategy.

  2. Characterising themes

    Time frame: Longitudinal data collection before, during and after the implementation

    Themes characterising the factors that influenced the observed implementation processes, based on the results from the contextual analysis.

  3. Comprehensive Complication Index (CCI®)

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

    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.

  4. Severe iAEs according to ClassIntra®

    Time frame: Difference in number of severe iAEs before and after the implementation

    Severe iAEs according to ClassIntra® are defined as greater than or equal to grade III.

  5. Total number of iAEs according to ClassIntra®

    Time frame: Difference in total number of iAEs before and after the implementation

    Total number of iAEs according to ClassIntra® occurring in the baseline and the after implementation period.

  6. Severe pAEs according to Clavien-Dindo

    Time frame: Difference in number of severe iAEs before and after the implementation

    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.

  7. Total number of pAEs according to Clavien-Dindo

    Time frame: Difference in total number of pAEs before and after the implementation

    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.

  8. Number of resulting actions due to the routine recording and discussion of iAEs during the sign-out

    Time frame: Difference in number of resulting actions before and after the implementation

    Resulting actions are e.g. preventive measures for anticipated pAEs.

  9. Length of hospital stay

    Time frame: Difference in length of hospital stay before and after the implementation

    Length of hospital stay will be measured in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Salome Dell-Kuster, Prof. Dr. med.

CONTACT

[email protected]

+41 61 328 64 74

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: CIBOSurg

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.