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

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ClinicalTrials.gov Identifier: NCT04016454
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by (Responsible Party):
University Hospital Muenster

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.

Condition or disease Intervention/treatment Phase
Anesthesia Adverse Effect of Handovers of Anesthesia Care Procedure: Intervention Not Applicable

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 : 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:

  1. Intervention group: handover of anesthesia
  2. Control group: no handover of anesthesia
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
Experimental: Intervention group
Complete handover of anesthesia care
Procedure: Intervention
There will be one complete handover

No Intervention: Control group
No handover of anesthesia care



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of participants with all-cause mortality [ Time Frame: within 30 days of index surgery ]
  2. Numer of participants with readmission to any hospital [ Time Frame: within 30 days of index surgery ]
  3. 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

  4. Hospital length of stay [ Time Frame: within 30 days of index surgery ]
  5. Number of patients with ICU admission [ Time Frame: within 30 days of index surgery ]
  6. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Melanie Mersch, MD, PHD +49 251-8347255 meersch@uni-muenster.de

Locations
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Germany
University Hospital Muenster Recruiting
Muenster, Germany, D-48149
Contact: Melanie Meersch, PhD, MD         
Sponsors and Collaborators
University Hospital Muenster
Else Kröner Fresenius Foundation
Investigators
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Principal Investigator: Melanie Meersch, MD, PHD University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04016454     History of Changes
Other Study ID Numbers: 04-AnIt-18
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
handover
intraoperative
anesthesia
adverse outcomes
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs