NCT04226391 is a clinical trial in Intraoperative Flow Disruptions, sponsored by Ludwig-Maximilians - University of Munich.

Who is sponsoring NCT04226391?

NCT04226391 is sponsored by Ludwig-Maximilians - University of Munich.

What condition does NCT04226391 study?

NCT04226391 studies Intraoperative Flow Disruptions.

Is NCT04226391 still recruiting?

NCT04226391 is currently completed. Last updated 13 April 2022.

Last reviewed 2022-04-13 · How we verify

NCT04226391

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 13 April 2022

What this trial tests

trial in Intraoperative Flow Disruptions in 75 participants. Completed in 30 October 2021.

Timeline

15 January 2020

Primary endpoint
31 December 2020

30 October 2021

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Status	Completed
Study type	OBSERVATIONAL
Enrollment	75
Start date	15 January 2020
Primary completion	31 December 2020
Estimated completion	30 October 2021
Sites	1 location across Germany

Conditions studied

Intraoperative Flow Disruptions — all drugs for Intraoperative Flow Disruptions →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Intraoperative Flow Disruptions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Associations of flow disruptions with patient, staff, and process outcomes: a prospective observational study of robotic-assisted radical prostatectomies.
Koch A, Quartucci C, Buchner A, Schlenker B, et al · · 2023 · cited 4× · PMID 37336845 · DOI 10.1007/s00464-023-10162-2

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04226391 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich
Last refreshed: 13 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04226391.

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