ClassIntra® for Better Outcomes in Surgery - CIBOSurg

Официальное название

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

Обзор

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.

Вмешательства

• Другое Observational study
  No intervention, observational only

Первичные конечные точки

• Intervention fidelity - component checklist completion [Срок оценки: 2 months after the end of the implementation]

Вторичные конечные точки (7)

• Intervention fidelity - component quality of checklist performance [Срок оценки: Up to four months after the implementation]
• Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps [Срок оценки: Up to four months after the implementation]
• Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory [Срок оценки: Measured after the implementation]
• Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted [Срок оценки: 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 [Срок оценки: Measured after the implementation]
• Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting [Срок оценки: Measured after the implementation]
• Sustainment [Срок оценки: 12 months after the last patient out]

Критерии участия

Критерии включения

\- 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 9 центров

• University Hospital Basel — Basel
• Lindenhofspital — Bern
• University Hospital Berne — Bern
• Cantonal Hospital Graubünden — Chur
• University Hospital Geneva — Geneva
• University Hospital Lausanne — Lausanne
• Cantonal Hospital Lucerne — Lucerne
• Regional Hospital Lugano — Lugano
• … и ещё 1 центр

Нидерланды · 1 центр

• Radboud UMC — Nijmegen

Идентификаторы

NCT: NCT05818332 · Req-2023-00330

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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