Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients

NCT06265168 | Active Not Recruiting

• 1 other identifier: req-2023-01512; am23Sutter3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coma

Keywords

high-fidelity simulation; observational study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Participants' self-evaluation of their performance in hindsight

  1 time assessment directly after the intervention (approx. 10 minutes in total)

Study Arms (1)

Physicians

Volunteering intensivists, emergency physicians, internists, and neurologists.

Other: Simulation

Interventions

Simulation OTHER

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.

Physicians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40711621 DERIVED

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Sutter, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: November 21, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CH (1)