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Electrophysiological Tests on Unconscious Patient

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858400


Locations
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Turkey
Mehmet Akif YAZAR
Nevsehir, Turkey, 50100
Sponsors and Collaborators
Nevsehir Public Hospital
TC Erciyes University
Investigators
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Study Director: Mehmet Akif Yazar, MD Nevsehir Public Hospital
Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Nevsehir Public Hospital
ClinicalTrials.gov Identifier: NCT03858400    
Other Study ID Numbers: 2016/407
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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