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Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes (HandiCAP)

U

University Hospital Muenster

Status

Completed

Conditions

Adverse Effect of Handovers of Anesthesia Care
Anesthesia

Treatments

Procedure: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04016454
04-AnIt-18

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,817 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,817 participants in 2 patient groups

Intervention group
Experimental group
Description:
No handover of anesthesia care
Treatment:
Procedure: Intervention
Control group
No Intervention group
Description:
Complete handover of anesthesia care

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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