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Interruptions, Teamwork, Stress and Patient Outcomes in the Operating Room

L

Ludwig Maximilian University of Munich

Status

Completed

Conditions

Intraoperative Flow Disruptions

Study type

Observational

Funder types

Other

Identifiers

NCT04226391
FD&OUTCOME01

Details and patient eligibility

About

The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called "Flow Disruption Events" (FDs) with a potential risk to patient safety occur very often.

The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology.

Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients: Written consent, completed case
  • OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration

Exclusion criteria

  • OR visitors & students

Trial design

75 participants in 2 patient groups

RAS Partial Nephrectomy
RAS Radical Prostatectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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