ComaCOMANCT06265168
Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients
An observational study of Coma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coma
- What is being tested?
- Simulation
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Physicians from different medical specialties (including neurologists, intensivists, internists, and emergency medical doctors) with different duration of clinical experience working at the University Hospital Basel.
Who may be able to join
- The participant is a physician (one of the following specialties: Neurology, Intensive Care, Internal Medicine, Emergency Medicine)
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients - a Prospective High Fidelity Simulator Study
This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient.
Read the detailed description
Each participant will attend one study visit. For all participants, the investigators will offer an emergency high-fidelity simulator training workshop. The study will be presented as a learning situation, in which the participating physicians can train and improve their skills in medical emergencies. All participating physicians will be asked to complete two questionnaires (one before and one after the simulation). The first includes questions about age, medical knowledge, medical specialization, prior experience with simulator-based training, clinical experience, hours worked prior to simulation and their stress level (quantified as 0 [not stressed] and 10 [severely stressed]).
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
- Coma
- Being tested
- Simulation
- Keywords
- high-fidelity simulation, observational study
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Volunteering intensivists, emergency physicians, internists, and neurologists. Receives: Other: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient.
Measured: 1 time assessment before, during and directly after the intervention (approx. 30 minutes in total)
Secondary outcomes (2)
Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient
Measured: 1 time assessment during and directly after the intervention (approx. 30 minutes in total)
Participants' self-evaluation of their performance in hindsight
Measured: 1 time assessment directly after the intervention (approx. 10 minutes in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265168
- Sponsor's protocol ID
- req-2023-01512; am23Sutter3
- Acronym
- COMA
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40711621
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients - a Prospective High Fidelity Simulator Study
- ClinicalTrials.gov ID
- NCT06265168
- Acronym / sponsor ID
- COMA / req-2023-01512; am23Sutter3
- Conditions
- Coma
- Keywords
- high-fidelity simulation, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient.
Detailed description
Each participant will attend one study visit. For all participants, the investigators will offer an emergency high-fidelity simulator training workshop. The study will be presented as a learning situation, in which the participating physicians can train and improve their skills in medical emergencies. All participating physicians will be asked to complete two questionnaires (one before and one after the simulation). The first includes questions about age, medical knowledge, medical specialization, prior experience with simulator-based training, clinical experience, hours worked prior to simulation and their stress level (quantified as 0 [not stressed] and 10 [severely stressed]).
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: SimulationVolunteering intensivists, emergency physicians, internists, and neurologists. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians from different medical specialties (including neurologists, intensivists, internists, and emergency medical doctors) with different duration of clinical experience working at the University Hospital Basel.
Key inclusion criteria (3 listed)
- The participant is a physician (one of the following specialties: Neurology, Intensive Care, Internal Medicine, Emergency Medicine)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationPhysicians 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. | Other | Physicians |
Primary outcome
To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient.
Time frame: 1 time assessment before, during and directly after the intervention (approx. 30 minutes in total)
2 secondary outcomes
Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient
Time frame: 1 time assessment during and directly after the intervention (approx. 30 minutes in total)
Participants' self-evaluation of their performance in hindsight
Time frame: 1 time assessment directly after the intervention (approx. 10 minutes in total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 40711621Liliane 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient. (time frame: 1 time assessment before, during and directly after the intervention (approx. 30 minutes in total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.