ClassIntra® for Better Outcomes in Surgery - CIBOSurg

University Hospital Basel

Status: Enrolling

Conditions: Perioperative Patient Safety

Treatments: Other: Observational study

Study type: Observational

Funder types: Other

Identifiers

NCT05818332

Req-2023-00330

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,800 participants in 1 patient group

before and after implementation cohort

Description:

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)

Treatment:

Other: Observational study