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Major SurgeryAnCHorNCT04582513

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

An observational study of Major Surgery, run by University Hospital Heidelberg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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? Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Surgery
What is being tested?
AnCHor-Checklist implementation
How many people
300 participants
Where
1 siteGermany
Study dates
29 Oct 2020to Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

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

Germany1 site, 1 recruiting

  • Department of Anaesthesiology, University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Jan Larmann, MD/PhD, +49 (0)6221 56 ext. 39447, Jan.larmann@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

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

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?

Read the 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.

Conditions
Major Surgery
Being tested
AnCHor-Checklist implementation
Keywords
handover, anaesthesia, checklist, perioperative complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnCHor-Checklist implementationOther

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

Study groups in NCT04582513
Study groupRoleWhat they receive
Pre-checklist implementation groupPatients undergoing major elective surgery where intraoperative handover occurs. This handover is performed according to current hospital standard without a standardized checklist.
Post-checklist implementation groupPatients 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.
Receives: Other: AnCHor-Checklist implementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: within 30 days of index surgery

Secondary outcomes (25)

  1. Implementation of checklist

    Rate of correctly filed checklists

    Measured: on day of index surgery

  2. Determination of recruitment rate

    Rate of recruited patients in all recruitable patients

    Measured: within 30 days of index surgery

  3. 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

    Measured: within 48 hours after index surgery

  4. 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)

    Measured: within 30 days of index surgery

  5. 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)

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

  6. Insufficiency of anastomoses

    Number of patients with insufficiency of anastomoses defined by International Study Group of Rectal Cancer (ISREC)-definition

    Measured: within 30 days of index surgery

  7. Intra-abdominal abcess

    Number of patients with intra-abdominal abscess defined by imaging

    Measured: within 30 days of index surgery

  8. Pneumonia

    Number of patients with pneumonia defined as occurence of pneumonia verified by X-ray

    Measured: within 30 days of index surgery

  9. Atrial fibrillation

    Number of patients with atrial fibrillation defined as new onset of atrial fibrillation without any known episode prior to index surgery

    Measured: within 30 days of index surgery

  10. 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)

    Measured: within 30 days after index surgery

  11. New onset of hemodialysis

    Number of patients with new onset of need for renal replacement therapy

    Measured: within 30 days after index surgery

  12. Cardiac arrest

    Number of patients with cardiac arrest defined as the need for cardiopulmonary resuscitation

    Measured: within 30 days of index surgery

  13. 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

    Measured: during index surgery and within 30 days after index surgery

  14. Sepsis

    Number of patients with sepsis defined according to Sepsis3 guidelines

    Measured: within 30 days of index surgery

  15. Stroke

    Number of patients with stroke defined by verification in a CT scan

    Measured: within 30 days of index surgery

  16. Pulmonary embolism and deep venous thromboembolism

    Number of patients with pulmonary embolism and deep venous thromboembolism defined by verification in a CT scan

    Measured: within 30 days of index surgery

  17. 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)

    Measured: during the initial surgical procedure and within 30 days after index surgery

  18. unplanned return to operating room

    Number of patients with unplanned return to operating room within time frame

    Measured: within 30 days of index surgery

  19. Need for intervention

    Number of patients with interventions defined as endoscopy, Insertion of drains or stents

    Measured: within 30 days of index surgery

  20. Hospital length of stay

    Documented in patient charts

    Measured: within 30 days of index surgery

  21. ICU admission

    Number of patients with ICU admission

    Measured: within 30 days of index surgery

  22. ICU length of stay

    Documented in patient charts

    Measured: within 30 days of index surgery

  23. total morbidity

    defined by Comprehensive Complication Index (CCI)

    Measured: within 30 days of index surgery

  24. All-cause mortality

    Number of patients died within 30 days of index surgery

    Measured: within 30 days of index surgery

  25. Readmission to any hospital

    Number of patients with any readmission to an acute care hospital

    Measured: within 30 days of index surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start29 Oct 2020
  3. Primary completionApr 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582513
Sponsor's protocol ID
AnCHor
Acronym
AnCHor
Status last verified
Nov 2020
First submitted
26 Sep 2020
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29318277

  • 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.

    PubMed 25440620

  • 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.

    PubMed 25102312

  • 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.

    PubMed 27466034

  • 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.

    PubMed 22653454

  • 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.

    PubMed 24448849

  • 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.

    PubMed 25625256

  • 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.

    PubMed 19342529

Questions about this trial

What is this clinical trial studying?

An observational study of Major Surgery, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Larmann, MD PhD (06221/5636351, jan.larmann@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of mortality, hospital readmission and major postoperative complications (time frame: within 30 days of index surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582513, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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