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) |
Estimated Enrollment : | 1814 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 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 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
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No Intervention: Control group
Complete handover of anesthesia care
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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:
Exclusion Criteria:
Contact: Melanie Mersch, MD, PHD | +49 251-8347255 | meersch@uni-muenster.de |
Germany | |
University Hospital Aachen | Recruiting |
Aachen, Germany | |
University Hospital Bochum | Recruiting |
Bochum, Germany | |
Klinikum Dortmund | Recruiting |
Dortmund, Germany | |
St. Josefs-Hospital Dortmund-Hörde | Recruiting |
Dortmund, Germany | |
Florence-Nightingale-Krankenhaus | Recruiting |
Düsseldorf, Germany, 40489 | |
Universitätsmedizin Göttingen, Klinik für Anästhesiologie | Recruiting |
Göttingen, Germany | |
University Hospital Heidelberg | Recruiting |
Heidelberg, Germany | |
Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin | Recruiting |
Köln, Germany | |
University Hospital Muenster | Recruiting |
Muenster, Germany, D-48149 | |
Contact: Melanie Meersch, PhD, MD | |
Kliniken Maria Hilf | Recruiting |
Mönchengladbach, Germany | |
St. Franziskus Hospital | Recruiting |
Münster, Germany |
Principal Investigator: | Melanie Meersch, MD, PHD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine |
Tracking Information | |||||
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First Submitted Date ICMJE | June 27, 2019 | ||||
First Posted Date ICMJE | July 11, 2019 | ||||
Last Update Posted Date | October 8, 2020 | ||||
Actual Study Start Date ICMJE | June 21, 2019 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes | ||||
Official Title ICMJE | Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes | ||||
Brief 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. | ||||
Detailed 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | 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:
Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Intervention
There will be one complete handover
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
1814 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2021 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04016454 | ||||
Other Study ID Numbers ICMJE | 04-AnIt-18 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Hospital Muenster | ||||
Study Sponsor ICMJE | University Hospital Muenster | ||||
Collaborators ICMJE | Else Kröner Fresenius Foundation | ||||
Investigators ICMJE |
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PRS Account | University Hospital Muenster | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |