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Clinical Trials/NCT04226391
NCT04226391
Completed
Not Applicable

Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study

Ludwig-Maximilians - University of Munich1 site in 1 country75 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Flow Disruptions
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
75
Locations
1
Primary Endpoint
Patient Outcomes
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
October 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthias Weigl

Principal Investigator

Ludwig-Maximilians - University of Munich

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient Outcomes

Time Frame: 3 Months

Intra- and postoperative patient outcomes (Complications, functional outcomes etc.)

Intraoperative Teamwork

Time Frame: 4 Hours

Teamwork within the medical team including surgeons, nurses and anaesthetists

Stress, Mental Workload

Time Frame: 4 Hours

Intraoperative workload, perceived distraction and stress of medical team

Study Sites (1)

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