Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Anesthesia Clinical Trial

— HandiCAP  

Official title:

Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016454
• Other study ID #: 04-AnIt-18
• Status: Completed
• Phase: N/A
• 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
• 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

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