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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04226391

Enrollment

Registered

2020-01-13

Start date

2020-01-15

Completion date

2021-10-30

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Flow Disruptions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
Patient Outcomes	3 Months	Intra- and postoperative patient outcomes (Complications, functional outcomes etc.)

Countries

Germany

Outcome results