Electrophysiological Tests on Unconscious Patient
Electrophysiological Responses to External Stimuli of Patients Evaluated as Unconscious Patient in Critical Care Units: Preliminary Results of 10 Patients
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedMarch 27, 2019
March 1, 2019
1 year
February 27, 2019
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
40 minutes
Eligibility Criteria
All patients who be considered to be unconscious in our CCU's
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nevsehir Public Hospitallead
- TC Erciyes Universitycollaborator
Study Sites (1)
Mehmet Akif YAZAR
Nevşehir, 50100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 21096471BACKGROUNDSchnakers 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.
PMID: 19622138RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mehmet Akif Yazar, MD
Nevsehir Public Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2019
First Posted
February 28, 2019
Study Start
March 20, 2017
Primary Completion
March 31, 2018
Study Completion
August 31, 2018
Last Updated
March 27, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share