Clinical trial NCT05818332: ClassIntra® for Better Outcomes in Surgery - CIBOSurg
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Patient Safety
Keywords: Perioperative safety
sign-out
intraoperative adverse events
ClassIntra®
hybrid design
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intervention fidelity - component checklist completion
timeFrame: 2 months after the end of the implementation
Secondary outcomes:
measure: Intervention fidelity - component quality of checklist performance
timeFrame: Up to four months after the implementation
measure: Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps
timeFrame: Up to four months after the implementation
measure: Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory
timeFrame: Measured after the implementation
measure: Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted
timeFrame: Checklist and process modifications classified according to FRAME.
measure: Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting
timeFrame: Measured after the implementation
measure: Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting
timeFrame: Measured after the implementation
measure: Sustainment
timeFrame: 12 months after the last patient out
Other outcomes:
measure: Qualitative conclusions
timeFrame: Longitudinal data collection before, during and after the implementation
measure: Characterising themes
timeFrame: Longitudinal data collection before, during and after the implementation
measure: Comprehensive Complication Index (CCI®)
timeFrame: Difference in CCI® before and after the implementation at hospital discharge and at 90 days after surgery
measure: Severe iAEs according to ClassIntra®
timeFrame: Difference in number of severe iAEs before and after the implementation
measure: Total number of iAEs according to ClassIntra®
timeFrame: Difference in total number of iAEs before and after the implementation
measure: Severe pAEs according to Clavien-Dindo
timeFrame: Difference in number of severe iAEs before and after the implementation
measure: Total number of pAEs according to Clavien-Dindo
timeFrame: Difference in total number of pAEs before and after the implementation
measure: Number of resulting actions due to the routine recording and discussion of iAEs during the sign-out
timeFrame: Difference in number of resulting actions before and after the implementation
measure: Length of hospital stay
timeFrame: Difference in length of hospital stay before and after the implementation
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Berne
country: Switzerland
facility: Lindenhofspital
city: Bern
country: Switzerland
facility: University Hospital Berne
city: Chur
country: Switzerland
facility: Cantonal Hospital Graubünden
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
city: Lugano
country: Switzerland
facility: Regional Hospital Lugano
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References: