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?
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.
Study Type
OBSERVATIONAL
Enrollment
300
a standardized checklist using the SBAR concept according to the recommendations of the DGAI
Department of Anaesthesiology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGComposite 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
Time frame: within 30 days of index surgery
Implementation of checklist
Rate of correctly filed checklists
Time frame: on day of index surgery
Determination of recruitment rate
Rate of recruited patients in all recruitable patients
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: within the initial surgical procedure and within 30 days after index surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Insufficiency of anastomoses
Number of patients with insufficiency of anastomoses defined by International Study Group of Rectal Cancer (ISREC)-definition
Time frame: within 30 days of index surgery
Intra-abdominal abcess
Number of patients with intra-abdominal abscess defined by imaging
Time frame: within 30 days of index surgery
Pneumonia
Number of patients with pneumonia defined as occurence of pneumonia verified by X-ray
Time frame: 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
Time frame: 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)
Time frame: within 30 days after index surgery
New onset of hemodialysis
Number of patients with new onset of need for renal replacement therapy
Time frame: within 30 days after index surgery
Cardiac arrest
Number of patients with cardiac arrest defined as the need for cardiopulmonary resuscitation
Time frame: 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
Time frame: during index surgery and within 30 days after index surgery
Sepsis
Number of patients with sepsis defined according to Sepsis3 guidelines
Time frame: within 30 days of index surgery
Stroke
Number of patients with stroke defined by verification in a CT scan
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: within 30 days of index surgery
Need for intervention
Number of patients with interventions defined as endoscopy, Insertion of drains or stents
Time frame: within 30 days of index surgery
Hospital length of stay
Documented in patient charts
Time frame: within 30 days of index surgery
ICU admission
Number of patients with ICU admission
Time frame: within 30 days of index surgery
ICU length of stay
Documented in patient charts
Time frame: within 30 days of index surgery
total morbidity
defined by Comprehensive Complication Index (CCI)
Time frame: within 30 days of index surgery
All-cause mortality
Number of patients died within 30 days of index surgery
Time frame: within 30 days of index surgery
Readmission to any hospital
Number of patients with any readmission to an acute care hospital
Time frame: within 30 days of index surgery