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AnesthesiaHandiCAPNCT04016454

Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

A study testing Intervention in people with Anesthesia and Adverse Effect of Handovers of Anesthesia Care, run by University Hospital Muenster at 11 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,817 participants
Where
11 sitesGermany
Study dates
21 Jun 2019to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • University Hospital Aachen

    Aachen

  • University Hospital Bochum

    Bochum

  • Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin

    Cologne

  • Klinikum Dortmund

    Dortmund

  • St. Josefs-Hospital Dortmund-Hörde

    Dortmund

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • Universitätsmedizin Göttingen, Klinik für Anästhesiologie

    Göttingen

  • University Hospital Heidelberg

    Heidelberg

  • Kliniken Maria Hilf

    Mönchengladbach

  • University Hospital Muenster

    Münster, D-48149

  • St. Franziskus Hospital

    Münster

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Intervention
Keywords
handover, intraoperative, anesthesia, adverse outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionProcedure or surgery

    There will be one complete handover

Study groups in NCT04016454
Study groupRoleWhat they receive
Intervention groupExperimentalNo handover of anesthesia care
Receives: Procedure: Intervention
Control groupNo interventionComplete handover of anesthesia care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications

    Measured: within 30 days of index surgery

Secondary outcomes (6)

  1. Number of participants with all-cause mortality

    Measured: within 30 days of index surgery

  2. Numer of participants with readmission to any hospital

    Measured: within 30 days of index surgery

  3. 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

    Measured: within 30 days of index surgery

  4. Hospital length of stay

    Measured: within 30 days of index surgery

  5. Number of patients with ICU admission

    Measured: within 30 days of index surgery

  6. ICU length of stay

    Measured: within 30 days of index surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study start21 Jun 2019
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,817 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016454
Sponsor's protocol ID
04-AnIt-18
Acronym
HandiCAP
Status last verified
Dec 2021
First submitted
27 Jun 2019
Last updated
5 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meersch M, Weiss R, Kullmar M, Bergmann L, Thompson A, Griep L, Kusmierz D, Buchholz A, Wolf A, Nowak H, Rahmel T, Adamzik M, Haaker JG, Goettker C, Gruendel M, Hemping-Bovenkerk A, Goebel U, Braumann J, Wisudanto I, Wenk M, Flores-Bergmann D, Bohmer A, Cleophas S, Hohn A, Houben A, Ellerkmann RK, Larmann J, Sander J, Weigand MA, Eick N, Ziemann S, Bormann E, Gerss J, Sessler DI, Wempe C, Massoth C, Zarbock A. Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults: The HandiCAP Randomized Clinical Trial. JAMA. 2022 Jun 28;327(24):2403-2412. doi: 10.1001/jama.2022.9451.

    PubMed 35665794

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Anesthesia and Adverse Effect of Handovers of Anesthesia Care, run by University Hospital Muenster at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04016454, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.

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