An interventional study of Intervention in Anesthesia and Adverse Effect of Handovers of Anesthesia Care, sponsored by University Hospital Muenster. Completed at 11 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment
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.
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.
University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
No handover of anesthesia care
Procedure: Intervention
Complete handover of anesthesia care
There will be one complete handover
Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications
Time frame: within 30 days of index surgery
Number of participants with all-cause mortality
Time frame: within 30 days of index surgery
Numer of participants with readmission to any hospital
Time frame: within 30 days of index surgery
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
Time frame: within 30 days of index surgery
Hospital length of stay
Time frame: within 30 days of index surgery
Number of patients with ICU admission
Time frame: within 30 days of index surgery
ICU length of stay
Time frame: within 30 days of index surgery
Plan to share: No
Ran from Jun 2019 to primary completion in Jul 2021, 25 months.
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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