Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients
NCT ID: NCT06265168
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2024-03-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All physicians will be informed regarding the features of the high-fidelity mannequin (see respective subjection below), the equipment of the artificial emergency room, and the role of a resident in the emergency department. The second questionnaire will include questions aimed at understanding the clinical experience, knowledge, and conceptual understanding regarding diagnostics and management of coma. The simulation will be terminated after 20 minutes. All physicians will be exposed to the scenario once (the clinical case is detailed in the respective subjection below).
No information about the workshop's goal or the scenarios' content will be given to the physicians before the simulation. After the simulation, the physicians will be asked to perform a short self-assessment using an "emotion wheel simulation reflexivity" questionnaire.
The mannequin can talk, blink, open or close eyes and mouth, produce foamy sputum, enuresis, and move the pupils and extremities symmetrically or asymmetrically. The pupils can be reactive or unreactive to light. Pulses can be palpated, thoracic excursion and pulmonary sounds during breathing can be detected. The vital signs (including breathing frequency, heart rate, oxygenation, and blood pressure) and the electrocardiogram of the mannequin are displayed on a standard monitoring device at bedside. The simulator room will be equipped with a manual external defibrillator, standard emergency medications (including Vasopressors, Steroids, Antimicrobials, crystalloid fluid, Glucose-infusions etc), intubation equipment, suctioning tubes, bandages, a pocket flashlight (to check pupils) and a stethoscope. A printed version of the medical chart will contain a written report of the emergency medical service and laboratory results (including blood gas analysis and hemogram revealing normal values, normoglycemia, normal C-reactive protein serum concentration, normal thyroid-stimulating hormone levels, negative routine toxicologic screening results, elevated liver enzyme serum levels, normal measures of cerebrospinal fluid analysis, and an increased osmotic gap which will only be presented upon request of the physician). During the scenario, the programmed measures of vital signs of the mannequin (including breathing frequency, heart rate, oxygenation, and blood pressure) and their changes over time will be displayed on a standard bedside monitoring device and present normal values. An unremarkable cerebral computed tomogram will be displayed. An intravenous access will be pre-installed for the application of medications or fluids. During the simulation, a trained critical care study nurse (confederate) will be present to support the physician regarding the ascertainment of diagnostic results, attaching and initiating monitoring devices, and preparation. The study nurse is trained not to instruct physicians about the diagnostic workup or to reveal treatment algorithms and will administer drugs only at the physician's demand. The use of electronic devices to access institutional or international guidelines and literature is permitted. The entire scenario will be monitored by a mobile camera and microphone allowing simultaneous video and audio recording of the team performance and monitor findings. The recording will also be used for debriefing purposes and (if consent is given by the physician) for anonymized analyzes regarding the study aims. Debriefing sessions will be conducted individually after each training.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Physicians
Volunteering intensivists, emergency physicians, internists, and neurologists.
Simulation
Physicians will participate in a simulated scenario of an adult comatose patient. The intervention will be presented as a learning situation where the physician interacts with a high-fidelity mannequin. The mannequin simulating the patient will manifest a Glasgow Coma Score of 3 (improving over time to a GCS of 4) and a range of physiological and pathological symptoms. Physicians will have access to emergency equipment, including intubation equipment, a defibrillator, and medications. A trained nurse will be present to assist with the simulation. After 20 minutes the patient will regain consciousness in order to avoid a frustrating experience for the physicians. After simulation termination, a senior physician will join the resident and ask him to report the current scenario and will stop the simulation. The entire scenario will be video-recorded.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Simulation
Physicians will participate in a simulated scenario of an adult comatose patient. The intervention will be presented as a learning situation where the physician interacts with a high-fidelity mannequin. The mannequin simulating the patient will manifest a Glasgow Coma Score of 3 (improving over time to a GCS of 4) and a range of physiological and pathological symptoms. Physicians will have access to emergency equipment, including intubation equipment, a defibrillator, and medications. A trained nurse will be present to assist with the simulation. After 20 minutes the patient will regain consciousness in order to avoid a frustrating experience for the physicians. After simulation termination, a senior physician will join the resident and ask him to report the current scenario and will stop the simulation. The entire scenario will be video-recorded.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The participant practices medicine at the University Hospital Basel
* The participant has signed informed consent and agrees to be recorded (audio and video) during the study.
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Basel, Switzerland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raoul Sutter, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Basel
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Liliane N, Tisljar K, Berger S, De Marchis GM, Dittrich TD, Bassetti S, Bingisser R, Hunziker S, Marsch S, Sutter R. Comprehensive observations and multidisciplinary approaches (COMA) in the management of unconscious patients: a prospective high fidelity simulation study. J Neurol. 2025 Jul 25;272(8):537. doi: 10.1007/s00415-025-13228-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
req-2023-01512; am23Sutter3
Identifier Type: -
Identifier Source: org_study_id