Completed

NCT Number: NCT04226391

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

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.

Completed

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Key information

Conditions

Intraoperative Flow Disruptions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Munich, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
Patient Outcomes

Time frame: 3 Months

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jan 13, 2020
Registry last updated: Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.