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

NCT04582513 | Unknown

• 1 other identifier: AnCHor
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

Major Surgery

Keywords

handover; anaesthesia; checklist; perioperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Implementation of checklist

  on day of index surgery

• Determination of recruitment rate

  within 30 days of index surgery

• Prolonged postoperative Ventilation >48 hours

  within 48 hours after index surgery

• Major disruption of surgical wound

  within 30 days of index surgery

• Bleeding

  within the initial surgical procedure and within 30 days after index surgery

Study Arms (2)

Pre-checklist implementation group

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

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

Interventions

AnCHor-Checklist implementation OTHER

a standardized checklist using the SBAR concept according to the recommendations of the DGAI

Post-checklist implementation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective major non cardiac surgery, admitted to University Hospital Heidelberg

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 29318277 BACKGROUND

• 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.

  PMID: 25440620 BACKGROUND

• 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.

  PMID: 25102312 BACKGROUND

• 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.

  PMID: 27466034 BACKGROUND

• 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.

  PMID: 22653454 BACKGROUND

• 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.

  PMID: 24448849 BACKGROUND

• 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.

  PMID: 25625256 BACKGROUND

• 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.

  PMID: 19342529 BACKGROUND

Study Officials

• Jan Larmann, MD PhD

  Departement of Anaesthesiology, Heidelberg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Larmann, MD PhD

CONTACT

06221/5636351; jan.larmann@med.uni-heidelberg.de

Julia Sander, MD

CONTACT

06221/5636351; julia.Sander@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anaesthesiologist

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 9, 2020
• Study Start: October 29, 2020
• Primary Completion: April 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)