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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04016454
Other study ID # 04-AnIt-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2019
Est. completion date July 31, 2021

Study information

Verified date December 2021
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period.


Description:

Intraoperative handover of anesthesia care frequently occurs in clinical routine. Communication between the two anesthesiologists plays a pivotal role for the continuation of anesthesia care. The outgoing clinician must inform the incoming clinician in a short period of time about the important pre- and intraoperative facts and about the surgery while continuing to provide patient care. Contributing factors to inadequate communication during handoffs include insufficient or misleading information, busy and distractive environment, ineffective communication methods, lack of time, lack of standardized procedures, and insufficient staffing. It is estimated that the majority of adverse events in health care involve miscommunication during the handoff between physicians and perhaps other health care practitioners (https://www.jointcommission.org/hot_topics_toc/). The goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period. The investigators hypothesizes that handover of anesthesia care does increase the risk for adverse outcomes. The primary outcome parameter is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications (including prolonged postoperative ventilation ≥ 48 h, 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 endpoints are the individual criteria of the primary endpoint, hospital length of stay, ICU admission, and ICU length of stay. As the currently available data on handover of anesthesia care have not been obtained from prospective, randomized controlled trials, the results of the Handicap trial will bring new insights to anesthesia care to improve patients' outcome.


Recruitment information / eligibility

Status Completed
Enrollment 1817
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) - ASA 3-4 - Informed consent Exclusion Criteria: - 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 - Persons with any kind of dependency on the investigator or employed by the investigator

Study Design


Related Conditions & MeSH terms

  • Adverse Effect of Handovers of Anesthesia Care
  • Anesthesia

Intervention

Procedure:
Intervention
There will be one complete handover

Locations

Country Name City State
Germany University Hospital Aachen Aachen
Germany University Hospital Bochum Bochum
Germany Klinikum Dortmund Dortmund
Germany St. Josefs-Hospital Dortmund-Hörde Dortmund
Germany Florence-Nightingale-Krankenhaus Düsseldorf
Germany Universitätsmedizin Göttingen, Klinik für Anästhesiologie Göttingen
Germany University Hospital Heidelberg Heidelberg
Germany Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin Köln
Germany Kliniken Maria Hilf Mönchengladbach
Germany University Hospital Muenster Muenster
Germany St. Franziskus Hospital Münster

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Muenster Else Kröner Fresenius Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications within 30 days of index surgery
Secondary Number of participants with all-cause mortality within 30 days of index surgery
Secondary Numer of participants with readmission to any hospital within 30 days of index surgery
Secondary Number of participants with major postoperative complication predefined postoperative complication including prolonged postoperative ventilation = 48h, 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 Hospital length of stay within 30 days of index surgery
Secondary Number of patients with ICU admission within 30 days of index surgery
Secondary ICU length of stay within 30 days of index surgery
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