- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858400
Electrophysiological Tests on Unconscious Patient
March 25, 2019 updated by: Nevsehir Public Hospital
Electrophysiological Responses to External Stimuli of Patients Evaluated as Unconscious Patient in Critical Care Units: Preliminary Results of 10 Patients
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nevsehir, Turkey, 50100
- Mehmet Akif YAZAR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients who be considered to be unconscious in our CCU's
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
40 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mehmet Akif Yazar, MD, Nevsehir Public Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2017
Primary Completion (Actual)
March 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
February 27, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
February 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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