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

November 1, 2020 updated by: Jan Larmann, University Hospital Heidelberg

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Recruiting
        • Department of Anaesthesiology, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
a standardized checklist using the SBAR concept according to the recommendations of the DGAI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of mortality, hospital readmission and major postoperative complications
Time Frame: within 30 days of index surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implementation of checklist
Time Frame: on day of index surgery
Rate of correctly filed checklists
on day of index surgery
Determination of recruitment rate
Time Frame: within 30 days of index surgery
Rate of recruited patients in all recruitable patients
within 30 days of index surgery
Prolonged postoperative Ventilation >48 hours
Time Frame: within 48 hours after index surgery
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
within 48 hours after index surgery
Major disruption of surgical wound
Time Frame: within 30 days of index surgery
Number of patients with major disruption of surgical wound defined as the need for re-operation (wound dehiscence, burst abdomen)
within 30 days of index surgery
Bleeding
Time Frame: within the initial surgical procedure and within 30 days after index surgery
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)
within the initial surgical procedure and within 30 days after index surgery
Insufficiency of anastomoses
Time Frame: within 30 days of index surgery
Number of patients with insufficiency of anastomoses defined by International Study Group of Rectal Cancer (ISREC)-definition
within 30 days of index surgery
Intra-abdominal abcess
Time Frame: within 30 days of index surgery
Number of patients with intra-abdominal abscess defined by imaging
within 30 days of index surgery
Pneumonia
Time Frame: within 30 days of index surgery
Number of patients with pneumonia defined as occurence of pneumonia verified by X-ray
within 30 days of index surgery
Atrial fibrillation
Time Frame: within 30 days of index surgery
Number of patients with atrial fibrillation defined as new onset of atrial fibrillation without any known episode prior to index surgery
within 30 days of index surgery
Occurrence of moderate or severe acute kidney injury
Time Frame: within 30 days after index surgery
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)
within 30 days after index surgery
New onset of hemodialysis
Time Frame: within 30 days after index surgery
Number of patients with new onset of need for renal replacement therapy
within 30 days after index surgery
Cardiac arrest
Time Frame: within 30 days of index surgery
Number of patients with cardiac arrest defined as the need for cardiopulmonary resuscitation
within 30 days of index surgery
Myocardial infarction
Time Frame: during index surgery and within 30 days after index surgery
Number of patients with myocardial infarction defined by by ST elevation in the ECG and/or troponin elevation in patients with acute chest pain
during index surgery and within 30 days after index surgery
Sepsis
Time Frame: within 30 days of index surgery
Number of patients with sepsis defined according to Sepsis3 guidelines
within 30 days of index surgery
Stroke
Time Frame: within 30 days of index surgery
Number of patients with stroke defined by verification in a CT scan
within 30 days of index surgery
Pulmonary embolism and deep venous thromboembolism
Time Frame: within 30 days of index surgery
Number of patients with pulmonary embolism and deep venous thromboembolism defined by verification in a CT scan
within 30 days of index surgery
Shock
Time Frame: during the initial surgical procedure and within 30 days after index surgery
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)
during the initial surgical procedure and within 30 days after index surgery
unplanned return to operating room
Time Frame: within 30 days of index surgery
Number of patients with unplanned return to operating room within time frame
within 30 days of index surgery
Need for intervention
Time Frame: within 30 days of index surgery
Number of patients with interventions defined as endoscopy, Insertion of drains or stents
within 30 days of index surgery
Hospital length of stay
Time Frame: within 30 days of index surgery
Documented in patient charts
within 30 days of index surgery
ICU admission
Time Frame: within 30 days of index surgery
Number of patients with ICU admission
within 30 days of index surgery
ICU length of stay
Time Frame: within 30 days of index surgery
Documented in patient charts
within 30 days of index surgery
total morbidity
Time Frame: within 30 days of index surgery
defined by Comprehensive Complication Index (CCI)
within 30 days of index surgery
All-cause mortality
Time Frame: within 30 days of index surgery
Number of patients died within 30 days of index surgery
within 30 days of index surgery
Readmission to any hospital
Time Frame: within 30 days of index surgery
Number of patients with any readmission to an acute care hospital
within 30 days of index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANCHOR (Other Identifier: Cidara)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings