Clinical trial NCT04582513: Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome
Official title: Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome (AnCHor - Checklist) Pilot Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Surgery
Keywords: handover
anaesthesia
checklist
perioperative complications
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major non cardiac surgery, admitted to University Hospital Heidelberg

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of mortality, hospital readmission and major postoperative complications
timeFrame: within 30 days of index surgery
Secondary outcomes:
measure: Implementation of checklist
timeFrame: on day of index surgery
measure: Determination of recruitment rate
timeFrame: within 30 days of index surgery
measure: Prolonged postoperative Ventilation >48 hours
timeFrame: within 48 hours after index surgery
measure: Major disruption of surgical wound
timeFrame: within 30 days of index surgery
measure: Bleeding
timeFrame: within the initial surgical procedure and within 30 days after index surgery
measure: Insufficiency of anastomoses
timeFrame: within 30 days of index surgery
measure: Intra-abdominal abcess
timeFrame: within 30 days of index surgery
measure: Pneumonia
timeFrame: within 30 days of index surgery
measure: Atrial fibrillation
timeFrame: within 30 days of index surgery
measure: Occurrence of moderate or severe acute kidney injury
timeFrame: within 30 days after index surgery
measure: New onset of hemodialysis
timeFrame: within 30 days after index surgery
measure: Cardiac arrest
timeFrame: within 30 days of index surgery
measure: Myocardial infarction
timeFrame: during index surgery and within 30 days after index surgery
measure: Sepsis
timeFrame: within 30 days of index surgery
measure: Stroke
timeFrame: within 30 days of index surgery
measure: Pulmonary embolism and deep venous thromboembolism
timeFrame: within 30 days of index surgery
measure: Shock
timeFrame: during the initial surgical procedure and within 30 days after index surgery
measure: unplanned return to operating room
timeFrame: within 30 days of index surgery
measure: Need for intervention
timeFrame: within 30 days of index surgery
measure: Hospital length of stay
timeFrame: within 30 days of index surgery
measure: ICU admission
timeFrame: within 30 days of index surgery
measure: ICU length of stay
timeFrame: within 30 days of index surgery
measure: total morbidity
timeFrame: within 30 days of index surgery
measure: All-cause mortality
timeFrame: within 30 days of index surgery
measure: Readmission to any hospital
timeFrame: within 30 days of index surgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Anaesthesiology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Departement of Anaesthesiology, Heidelberg University Hospital
name: Jan Larmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones PM, Cherry RA, Allen BN, Jenkyn KMB, Shariff SZ, Flier S, Vogt KN, Wijeysundera DN. Association Between Handover of Anesthesia Care and Adverse Postoperative Outcomes Among Patients Undergoing Major Surgery. JAMA. 2018 Jan 9;319(2):143-153. doi: 10.1001/jama.2017.20040.
citation: Hudson CC, McDonald B, Hudson JK, Tran D, Boodhwani M. Impact of anesthetic handover on mortality and morbidity in cardiac surgery: a cohort study. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):11-6. doi: 10.1053/j.jvca.2014.05.018. Epub 2014 Nov 24.
citation: Saager L, Hesler BD, You J, Turan A, Mascha EJ, Sessler DI, Kurz A. Intraoperative transitions of anesthesia care and postoperative adverse outcomes. Anesthesiology. 2014 Oct;121(4):695-706. doi: 10.1097/ALN.0000000000000401.
citation: Terekhov MA, Ehrenfeld JM, Dutton RP, Guillamondegui OD, Martin BJ, Wanderer JP. Intraoperative Care Transitions Are Not Associated with Postoperative Adverse Outcomes. Anesthesiology. 2016 Oct;125(4):690-9. doi: 10.1097/ALN.0000000000001246.
citation: McCrory MC, Aboumatar H, Custer JW, Yang CP, Hunt EA. "ABC-SBAR" training improves simulated critical patient hand-off by pediatric interns. Pediatr Emerg Care. 2012 Jun;28(6):538-43. doi: 10.1097/PEC.0b013e3182587f6e.
citation: Randmaa M, Martensson G, Leo Swenne C, Engstrom M. SBAR improves communication and safety climate and decreases incident reports due to communication errors in an anaesthetic clinic: a prospective intervention study. BMJ Open. 2014 Jan 21;4(1):e004268. doi: 10.1136/bmjopen-2013-004268.
citation: Agarwala AV, Firth PG, Albrecht MA, Warren L, Musch G. An electronic checklist improves transfer and retention of critical information at intraoperative handoff of care. Anesth Analg. 2015 Jan;120(1):96-104. doi: 10.1213/ANE.0000000000000506.
citation: Marshall S, Harrison J, Flanagan B. The teaching of a structured tool improves the clarity and content of interprofessional clinical communication. Qual Saf Health Care. 2009 Apr;18(2):137-40. doi: 10.1136/qshc.2007.025247.