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Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04016454
Acronym
HandiCAP
Enrollment
1817
Registered
2019-07-11
Start date
2019-06-21
Completion date
2021-07-31
Last updated
2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Handovers of Anesthesia Care, Anesthesia

Keywords

handover, intraoperative, anesthesia, adverse 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.

Interventions

PROCEDUREIntervention

There will be one complete handover

Sponsors

Else Kröner Fresenius Foundation
CollaboratorOTHER
University Hospital Muenster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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: 1. Intervention group: handover of anesthesia 2. Control group: no handover of anesthesia

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complicationswithin 30 days of index surgery

Secondary

MeasureTime frameDescription
Numer of participants with readmission to any hospitalwithin 30 days of index surgery
Number of participants with major postoperative complicationwithin 30 days of index surgerypredefined 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
Number of participants with all-cause mortalitywithin 30 days of index surgery
Number of patients with ICU admissionwithin 30 days of index surgery
ICU length of staywithin 30 days of index surgery
Hospital length of staywithin 30 days of index surgery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026