Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Not Applicable

Completed

• Conditions: Adverse Effect of Handovers of Anesthesia Care; Anesthesia
• Interventions: Procedure: Intervention

• Registration Number: NCT04016454
• Lead Sponsor: University Hospital Muenster

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-21
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-11
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1817

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention	No handover of anesthesia care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with all-cause mortality	within 30 days of index surgery
Numer of participants with readmission to any hospital	within 30 days of index surgery
ICU length of stay	within 30 days of index surgery
Number of participants with major postoperative complication	within 30 days of index surgery	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
Hospital length of stay	within 30 days of index surgery
Number of patients with ICU admission	within 30 days of index surgery

Trial Locations

Locations (11)

University Hospital Bochum; 🇩🇪 Bochum, Germany

University Hospital Aachen; 🇩🇪 Aachen, Germany

Klinikum Dortmund; 🇩🇪 Dortmund, Germany

Florence-Nightingale-Krankenhaus; 🇩🇪 Düsseldorf, Germany

St. Josefs-Hospital Dortmund-Hörde; 🇩🇪 Dortmund, Germany

Universitätsmedizin Göttingen, Klinik für Anästhesiologie; 🇩🇪 Göttingen, Germany

Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin; 🇩🇪 Köln, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany

Kliniken Maria Hilf; 🇩🇪 Mönchengladbach, Germany

St. Franziskus Hospital; 🇩🇪 Münster, Germany

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany