Intraoperative Flow Disruptions Clinical Trial
Official title:
Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study
| Verified date | April 2022 |
| Source | Ludwig-Maximilians - University of Munich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | October 30, 2021 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Urological Clinic and Outpatient Clinic, University hospital of the Ludwig-Maximilians-University (LMU) Munich | Munich |
| Lead Sponsor | Collaborator |
|---|---|
| Ludwig-Maximilians - University of Munich |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intraoperative Teamwork | Teamwork within the medical team including surgeons, nurses and anaesthetists | 4 Hours | |
| Primary | Stress, Mental Workload | Intraoperative workload, perceived distraction and stress of medical team | 4 Hours | |
| Primary | Patient Outcomes | Intra- and postoperative patient outcomes (Complications, functional outcomes etc.) | 3 Months |