Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Conditions
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Anesthesia, Adverse Effect of Handovers of Anesthesia Care

Intervention / Treatment
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* Procedure: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Intervention group: handover of anesthesia Control group: no handover of anesthesia
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>No handover of anesthesia care | Procedure: Intervention<br>* There will be one complete handover<br>|
| No Intervention: Control group<br>Complete handover of anesthesia care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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handover, intraoperative, anesthesia, adverse outcomes