RecruitingNCT05818332

ClassIntra® for Better Outcomes in Surgery - 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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

1,800 participants

Start Date

Jul 17, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 110 Years

Inclusion Criteria1

  • \- 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 Criteria4

  • 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

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Interventions

OTHERObservational study

No intervention, observational only


Locations(10)

Radboud UMC

Nijmegen, Netherlands

University Hospital Basel

Basel, Switzerland

Lindenhofspital

Bern, Switzerland

University Hospital Berne

Bern, Switzerland

Cantonal Hospital Graubünden

Chur, Switzerland

University Hospital Geneva

Geneva, Switzerland

University Hospital Lausanne

Lausanne, Switzerland

Cantonal Hospital Lucerne

Lucerne, Switzerland

Regional Hospital Lugano

Lugano, Switzerland

University Hospital Zurich

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05818332