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.