Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients

Coma Clinical Trial

— COMA  

Official title:

Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients - a Prospective High Fidelity Simulator Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265168
• Other study ID #: req-2023-01512; am23Sutter3
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raoul Sutter, Prof. Dr.
• Phone: +41 61 32 87928
• Email: raoul.sutter[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Coma
• Unconsciousness

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient.		1 time assessment before, during and directly after the intervention (approx. 30 minutes in total)
Secondary	Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient		1 time assessment during and directly after the intervention (approx. 30 minutes in total)
Secondary	Participants' self-evaluation of their performance in hindsight		1 time assessment directly after the intervention (approx. 10 minutes in total)