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Conditions of BrainNCT03858400

Electrophysiological Tests on Unconscious Patient

An observational study of Conditions of Brain, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Conditions of Brain
How many people
10 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Mar 2017to 31 Aug 2018
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mehmet Akif YAZAR

    Nevşehir, 50100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
Unconscious patient, critical care unit, electrophysiological test
Medical subject headings
Brain Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electrophysiological evaluating

    To detect electrophysiologically that patients who were thought to be unconscious were responsive to the external stimuli of health providers and relatives.

    Measured: 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start20 Mar 2017
  3. Primary completion31 Mar 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
10 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03858400
Sponsor's protocol ID
2016/407
Status last verified
Mar 2019
First submitted
27 Feb 2019
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21096471
  • 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.

    PubMed 19622138

Questions about this trial

What is this clinical trial studying?

An observational study of Conditions of Brain, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrophysiological evaluating (time frame: 40 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03858400, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.

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