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

University Hospital Heidelberg

Status: Unknown

Conditions: Major Surgery

Treatments: Other: AnCHor-Checklist implementation

Study type: Observational

Funder types: Other

Identifiers

NCT04582513

AnCHor

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Pre-checklist implementation group

Description:

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

Description:

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.

Treatment:

Other: AnCHor-Checklist implementation