Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome

Study Overview
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Brief Summary
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The aim of the study is to collect information on feasibility and effect size of a confirmatory, prospective study with the question: Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications?

Detailed Description
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During clinical routine, intraoperative handover of anaesthesia care occurs frequently. This handover between two anaesthesiologists requires the transmission of all relevant information concerning the patient and the ongoing procedure. Studies regarding the influence of such handovers on patient outcome are inconclusive and mostly of retrospective nature. Some studies report a negative effect of handovers on patients mortality and outcome, however studies exist reporting no effect. A positive effect of intraoperative handovers as a result of a second man effect ist also possible. To increase handover quality, the German Society of Anaesthesiology and Intensive Care Medicine (DGAI) recommends the application of the situation, background, assessment and recommendation (SBAR) concept. Information are arranged in those four groups with the goal of structuring the handover and incorporating all relevant information. Studies show increased accuracy of transferred information and improved comprehensibility when using the SBAR concept. Whether an intraoperative handover according to the SBAR concept reduces the rate of postoperative complications is not yet investigated. Due to lack of information regarding feasibility and effect size, the investigators plan a prospective pilot study to answer these questions. Initially, patients undergoing major surgery are recruited where handover is performed without a standardized handover. After the implementation of a checklist using the SBAR concept, this checklist will be used during intraoperative handover in recruited patients where a handover occurs. The primary endpoint is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications. Additionally, implementation rate and efficacy of the checklist will be evaluated.

Official Title
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Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome (AnCHor - Checklist) Pilot Trial

Conditions
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Major Surgery

Intervention / Treatment
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* Other: AnCHor-Checklist implementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Major surgeries with a duration of at least 2 h (requirement of postoperative admission to hospital for at least 1 night) American Society of Anesthesiologists (ASA) Classification 3-4 Informed consent Exclusion Criteria: Patients incapable of consent Previous surgery within the same surgical subgroup within the last 6 months Pregnancy, breastfeeding Patients participating in another interventional trial within the last 3 months with possible interference to the outcome of this study Persons with any kind of dependency on the investigator or employed by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-checklist implementation group<br>Patients undergoing major elective surgery where intraoperative handover occurs. This handover is performed according to current hospital standard without a standardized checklist. | |
| Post-checklist implementation group<br>Patients undergoing major elective surgery where intraoperative handover occurs. This handover is performed after implementation of the AnCHor-CHecklist, a standardized checklist based on the SBAR concept. | Other: AnCHor-Checklist implementation<br>* a standardized checklist using the SBAR concept according to the recommendations of the DGAI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of mortality, hospital readmission and major postoperative complications | Number of patients that die and/or are readmitted to any hospital and/or experience any of the following: prolonged postoperative ventilation >48 hours, major disruption of surgical wound, bleeding, pneumonia, atrial fibrillation, moderate or severe acute kidney injury, new onset of hemodialysis, cardiac arrest, myocardial infarction, sepsis, stroke, pulmonary embolism, deep venous thrombosis, shock, unplanned return to operating room | within 30 days of index surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation of checklist | Rate of correctly filed checklists | on day of index surgery | 
| Determination of recruitment rate | Rate of recruited patients in all recruitable patients | within 30 days of index surgery | 
| Prolonged postoperative Ventilation >48 hours | Number of patients with prolonged postoperative ventilation defined as ≥ 48h need of invasive mechanical ventilation via endotracheal tube or need for tracheostomy due to prolonged weaning | within 48 hours after index surgery | 
| Major disruption of surgical wound | Number of patients with major disruption of surgical wound defined as the need for re-operation (wound dehiscence, burst abdomen) | within 30 days of index surgery | 
| Bleeding | Number of patients with bleeding complications defined as major bleeding with transfusion requirement and/ or the need for re-operation (hematothorax, relaparotomy, and removal of hematoma) | within the initial surgical procedure and within 30 days after index surgery | 
| Insufficiency of anastomoses | Number of patients with insufficiency of anastomoses defined by International Study Group of Rectal Cancer (ISREC)-definition | within 30 days of index surgery | 
| Intra-abdominal abcess | Number of patients with intra-abdominal abscess defined by imaging | within 30 days of index surgery | 
| Pneumonia | Number of patients with pneumonia defined as occurence of pneumonia verified by X-ray | within 30 days of index surgery | 
| Atrial fibrillation | Number of patients with atrial fibrillation defined as new onset of atrial fibrillation without any known episode prior to index surgery | within 30 days of index surgery | 
| Occurrence of moderate or severe acute kidney injury | Number of patients with moderate acute kidney injury (AKI) defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (≥ 2-fold increase in serum-creatinine from baseline and/or urine output < 0.5 ml/kg/h for ≥ 12 h) or severe AKI is defined as KDIGO stage 3 (≥ 3-fold serum creatinine increase from baseline and/or urine output ≤ 0.3 ml/kg/h for ≥ 24 h) | within 30 days after index surgery | 
| New onset of hemodialysis | Number of patients with new onset of need for renal replacement therapy | within 30 days after index surgery | 
| Cardiac arrest | Number of patients with cardiac arrest defined as the need for cardiopulmonary resuscitation | within 30 days of index surgery | 
| Myocardial infarction | Number of patients with myocardial infarction defined by by ST elevation in the ECG and/or troponin elevation in patients with acute chest pain | during index surgery and within 30 days after index surgery | 
| Sepsis | Number of patients with sepsis defined according to Sepsis3 guidelines | within 30 days of index surgery | 
| Stroke | Number of patients with stroke defined by verification in a CT scan | within 30 days of index surgery | 
| Pulmonary embolism and deep venous thromboembolism | Number of patients with pulmonary embolism and deep venous thromboembolism defined by verification in a CT scan | within 30 days of index surgery | 
| Shock | Number of patients with shock defined based on the corresponding International Statistical Classification of Diseases and Related Health Problems (ICD-10) codes (R57.1, R57.8, R57.9) | during the initial surgical procedure and within 30 days after index surgery | 
| unplanned return to operating room | Number of patients with unplanned return to operating room within time frame | within 30 days of index surgery | 
| Need for intervention | Number of patients with interventions defined as endoscopy, Insertion of drains or stents | within 30 days of index surgery | 
| Hospital length of stay | Documented in patient charts | within 30 days of index surgery | 
| ICU admission | Number of patients with ICU admission | within 30 days of index surgery | 
| ICU length of stay | Documented in patient charts | within 30 days of index surgery | 
| total morbidity | defined by Comprehensive Complication Index (CCI) | within 30 days of index surgery | 
| All-cause mortality | Number of patients died within 30 days of index surgery | within 30 days of index surgery | 
| Readmission to any hospital | Number of patients with any readmission to an acute care hospital | within 30 days of index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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handover, anaesthesia, checklist, perioperative complications