Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes (HandiCAP)
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ClinicalTrials.gov Identifier: NCT04016454 |
Recruitment Status :
Completed
First Posted : July 11, 2019
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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Anesthesia Adverse Effect of Handovers of Anesthesia Care | Procedure: Intervention | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1817 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | In order to investigate the impact of handover of anesthesia care on adverse postoperative outcomes, patients will be assigned to the two randomization groups:
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Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes |
Actual Study Start Date : | June 21, 2019 |
Actual Primary Completion Date : | July 31, 2021 |
Actual Study Completion Date : | July 31, 2021 |
Arm | Intervention/treatment |
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Experimental: Intervention group
No handover of anesthesia care
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Procedure: Intervention
There will be one complete handover |
No Intervention: Control group
Complete handover of anesthesia care
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- 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 [ Time Frame: 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 [ 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016454
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, 40489 | |
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 | |
University Hospital Muenster | |
Muenster, Germany, D-48149 | |
Kliniken Maria Hilf | |
Mönchengladbach, Germany | |
St. Franziskus Hospital | |
Münster, Germany |
Principal Investigator: | Melanie Meersch, MD, PHD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine |
Responsible Party: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT04016454 |
Other Study ID Numbers: |
04-AnIt-18 |
First Posted: | July 11, 2019 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
handover intraoperative anesthesia adverse outcomes |