Electrophysiological Tests on Unconscious Patient

• ClinicalTrials.gov Identifier: NCT03858400
• Recruitment Status: Completed
• First Posted: February 28, 2019
• Last Update Posted: March 27, 2019
• Sponsor: Nevsehir Public Hospital
• Collaborator: TC Erciyes University
• Information provided by (Responsible Party): Nevsehir Public Hospital

Study Description

Brief Summary:

Most patients with minimal consciousness status in Critical Care Units (CCU) are considered as an 'unconscious patient' with a neurological examination. Evaluating these patients as unconscious patients may lead to neglect of psychosocial needs in patient-care, a continuation of unchanged treatment protocols for a long time and desperate evaluation of prognosis. In this study, the investigators aimed to evaluate the emotional responses of patients who were considered by the healthcare providers and relatives of patients as an 'unconscious patient' by using electrophysiological tests.

Condition or disease
Conditions of Brain

Detailed Description:

Most patients with minimal consciousness status in Critical Care Units (CCU) are considered as an 'unconscious patient' with a neurological examination. A study showed that only 5% of intensive care nurses communicate with the unconscious patients and the content of the communication with them is to explain only the procedures to apply. Lack of communication with these patients can be transformed into the sense of 'non-responsive patient' among healthcare providers. Evaluating these patients as unconscious patients may lead to neglect of psychosocial needs in patient-care, a continuation of unchanged treatment protocols for a long time and desperate evaluation of prognosis. Moreover, it may lead to burnout syndrome over time for physicians and nurses in the CCU. In particular, the futile care perception of caregiving about unconscious patient prolongs the recovery process and length of stay in CCU. On the other hand, it may lead to the occupation of beds and increases the costs. Coma and sedation scoring systems such as Glasgow Coma Scale (GCS), Ramsey Sedation Scale (RSS) and Full Outline of Unresponsiveness (FOUR) have traditionally been used to assess the consciousness in CCU. These scoring systems may be insufficient to assess the psychophysiological status of the patients. Some researches on the unconscious patients have shown that these patients are aware of their surroundings. However, the data for these studies were obtained from interviews with patients who were previously experiencing unconsciousness, or with caregivers in CCU. The balance between sympathetic and parasympathetic systems is controlled by the autonomic nervous system. The response of the sympathetic system to external stimuli is different in many organs of the body. For example, a painful stimulus causes myosis in the eyes, hypertension, and tachycardia. Emotional stimuli also activate the sympathetic system. Fear and excitement lead to mydriasis, elevation of blood pressure and tachycardia, and activation of eccrine gland increase to release of sweating. Electrophysiological tests are objective methods in which the physiological signals and psychological states of emotion are acquired by noninvasively connected superficial electrodes. Through this method, the R-R interval (velocity analysis) can be evaluated by the Poincare Plot analysis in the electrocardiogram (ECG) to measure the electrical activity of the heart. Electrooculography (EOG) is a test that evaluates the eyes movements. In EOG, the source of the signals is the stationary electrical potential between the cornea and the retina. The EOG is composed of the changes of the electricity based on the movements of the eyeball around the eye center. Galvanic skin response (GSR) is a test used to measure skin conductivity and reflects electrodermal activity. In addition, blood pressure and pulse rate (PR) measurements provide information about the psychophysiological status of patients as a result of a sympathetic activity. In this study, the investigators aimed to evaluate the emotional responses of patients who were considered by the healthcare providers and relatives of patients as an 'unconscious patient' by using electrophysiological tests.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Other
• Target Follow-Up Duration: 6 Months
• Official Title: Electrophysiological Responses to External Stimuli of Patients Evaluated as Unconscious Patient in Critical Care Units: Preliminary Results of 10 Patients
• Actual Study Start Date: March 20, 2017
• Actual Primary Completion Date: March 31, 2018
• Actual Study Completion Date: August 31, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Electrophysiological evaluating [ Time Frame: 40 minutes ]
   To detect electrophysiologically that patients who were thought to be unconscious were responsive to the external stimuli of health providers and relatives.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All patients who be considered to be unconscious in our CCU's

Criteria

Inclusion Criteria:

• Patients with GCS score of 3,
• GCS score of 4 or 5 only when their motor response is 2 or 3,
• ≥18 years of age

Exclusion Criteria:

• Patients with GCS score ≥6,
• taking medication for sedation,
• motor neuron diseases such as ALS,
• suspected or actual brain death
• under 18 years of age

Contacts and Locations

Locations

Turkey

Mehmet Akif YAZAR

Nevsehir, Turkey, 50100

Sponsors and Collaborators

Nevsehir Public Hospital

TC Erciyes University

Investigators

• Study Director: Mehmet Akif Yazar, MD; Nevsehir Public Hospital

More Information

Additional Information:

Publications of Results:

Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.

Other Publications:

Wieser M, Buetler L, Koenig A, Riener R. Quantitative description of the state of awareness of patients in vegetative and minimally conscious state. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:5533-6. doi: 10.1109/IEMBS.2010.5626763.

• Responsible Party: Nevsehir Public Hospital
• ClinicalTrials.gov Identifier: NCT03858400
• Other Study ID Numbers: 2016/407
• First Posted: February 28, 2019
• Last Update Posted: March 27, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nevsehir Public Hospital:

Unconscious patient; critical care unit; electrophysiological test

Additional relevant MeSH terms:

Unconsciousness; Brain Diseases; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Central Nervous System Diseases