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

Completed

• Conditions: Intraoperative Flow Disruptions

• Registration Number: NCT04226391
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-01-15
• Primary Completion: 2020-12-31
• Study Completion: 2021-10-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

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