NCT04016454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,817

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

2.1 years

First QC Date

June 27, 2019

Last Update Submit

January 4, 2022

Conditions

AnesthesiaAdverse Effect of Handovers of Anesthesia Care

Keywords

handoverintraoperativeanesthesiaadverse outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    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

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

No handover of anesthesia care

Procedure: Intervention

Control group

NO INTERVENTION

Complete handover of anesthesia care

Interventions

InterventionPROCEDURE

There will be one complete handover

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Hospital Aachen

Aachen, Germany

Location

University Hospital Bochum

Bochum, Germany

Location

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

Cologne, Germany

Location

Klinikum Dortmund

Dortmund, Germany

Location

St. Josefs-Hospital Dortmund-Hörde

Dortmund, Germany

Location

Florence-Nightingale-Krankenhaus

Düsseldorf, 40489, Germany

Location

Universitätsmedizin Göttingen, Klinik für Anästhesiologie

Göttingen, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Kliniken Maria Hilf

Mönchengladbach, Germany

Location

University Hospital Muenster

Münster, D-48149, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35665794DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Melanie Meersch, MD, PHD

    University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 11, 2019

Study Start

June 21, 2019

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

January 5, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(11)