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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Flow Disruptions

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Urological Clinic and Outpatient Clinic, University hospital of the Ludwig-Maximilians-University (LMU) Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery in one of the participating departments

Surgical teams including surgeons, nurses and anesthetists

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RAS Partial Nephrectomy
RAS Radical Prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Teamwork	Teamwork within the medical team including surgeons, nurses and anaesthetists	4 Hours
Stress, Mental Workload	Intraoperative workload, perceived distraction and stress of medical team	4 Hours
Patient Outcomes	Intra- and postoperative patient outcomes (Complications, functional outcomes etc.)	3 Months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FD&OUTCOME01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No