Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Else Kröner Fresenius Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | No handover of anesthesia care |
|
| Control group | No Intervention | Complete handover of anesthesia care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Procedure | There will be one complete handover |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications | within 30 days of index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melanie Meersch, MD, PHD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Aachen | Aachen | Germany | ||||
| University Hospital Bochum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35665794 | Derived | Meersch M, Weiss R, Kullmar M, Bergmann L, Thompson A, Griep L, Kusmierz D, Buchholz A, Wolf A, Nowak H, Rahmel T, Adamzik M, Haaker JG, Goettker C, Gruendel M, Hemping-Bovenkerk A, Goebel U, Braumann J, Wisudanto I, Wenk M, Flores-Bergmann D, Bohmer A, Cleophas S, Hohn A, Houben A, Ellerkmann RK, Larmann J, Sander J, Weigand MA, Eick N, Ziemann S, Bormann E, Gerss J, Sessler DI, Wempe C, Massoth C, Zarbock A. Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults: The HandiCAP Randomized Clinical Trial. JAMA. 2022 Jun 28;327(24):2403-2412. doi: 10.1001/jama.2022.9451. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
In order to investigate the impact of handover of anesthesia care on adverse postoperative outcomes, patients will be assigned to the two randomization groups:
Not provided
Not provided
Not provided
| 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 |
| Hospital length of stay | within 30 days of index surgery |
| Number of patients with ICU admission | within 30 days of index surgery |
| ICU length of stay | within 30 days of index surgery |
| Bochum |
| Germany |
| Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin | Cologne | Germany |
| Klinikum Dortmund | Dortmund | Germany |
| St. Josefs-Hospital Dortmund-Hörde | Dortmund | Germany |
| Florence-Nightingale-Krankenhaus | Düsseldorf | 40489 | Germany |
| Universitätsmedizin Göttingen, Klinik für Anästhesiologie | Göttingen | Germany |
| University Hospital Heidelberg | Heidelberg | Germany |
| Kliniken Maria Hilf | Mönchengladbach | Germany |
| University Hospital Muenster | Münster | D-48149 | Germany |
| St. Franziskus Hospital | Münster | Germany |