- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362346
Signal Analysis for Neurocritical Patients
June 3, 2018 updated by: Yi-Hsin Tsai, Far Eastern Memorial Hospital
Analysis of Physiological Signals From Neurocritical Patients in Intensive Care Units Using Wavelet Transform and Deep Learning
The project uses big data analysis techniques such as wavelet transform and deep learning to analyze physiological signals from neurocritical patients and build a model to evaluate intracranial condition and to predict neurological outcome.
By identification of correlations among these parameters and their trends, we may achieve early detection of anomalies and enhance the ability in judgement of current neurological condition and prediction of prognosis.
By continuous input of the past and contemporary data in the ICU, the model will be modified repeatedly and its accuracy improves as the model grows.
The model can be used to recognize abnormalities earlier and provide a warning system.
Clinicians taking care of neurocritical patients can adjust their treatment policy and evaluate the outcome according to such system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
156
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
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New Taipei City, Taiwan, 200
- Far Eastern Memorial Hospital
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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
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurocritical patients admitted to intensive care unit (ICU), including but not limited to traumatic brain injury, hemorrhagic stroke, ischemic stroke, brain infection, brain tumor and acute hydrocephalus.
Description
Inclusion Criteria:
- Age equal to or older than 20 years
- Neurocritical patients admitted to intensive care unit (ICU), including but not limited to traumatic brain injury, hemorrhagic stroke, ischemic stroke, brain infection, brain tumor and acute hydrocephalus.
- Patients who have undergone cranial surgery and had intracranial pressure monitor inserted or external ventricular drainage. The central monitor of ICU is able to collect the data continuously
Exclusion Criteria:
- Age younger than 20 years.
- Continuous monitoring of intracranial pressure is not feasible.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Neurocritical patients
Patients with brain injury from trauma, ischemic stroke, hemorrhage stroke (intracerebral hemorrhage, subarachnoid hemorrhage), brain tumor with increased intracranial pressure, brain infection, hydrocephalus, among others.
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The patients may have either intracranial pressure (ICP) monitor insertion or external ventricular drainage that can be used as ICP monitor.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological status
Time Frame: Discharge out of the intensive care unit, averaged 2 weeks
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Glasgow coma scale/Mortality
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Discharge out of the intensive care unit, averaged 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yi-Hsin Tsai, M.D., Far Eastern Memorial 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
- Diederik P. Kingma and Jimmy Lei Ba. Adam: A method for stochastic optimization. Conference paper at ICLR 2015.
- Michael Unser and Akram Aldroubi. (1996 Apr) A review of wavelets in biomedical applications. Proceedings of the IEEE 84(4): 626-638.
- LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539.
- Christopher Torrence and Gilbert P. Compo. (1998 Jan) A practical guide to wavelet analysis. Bulletin of the American Meteorological Society 79(1):61-78.
- Theis, Fabian & Meyer-Base, Anke. (2010). Biomedical Signal Analysis - Contemporary Methods and Applications. Biomedical Signal Analysis: Contemporary Methods and Applications.
- Min S, Lee B, Yoon S. Deep learning in bioinformatics. Brief Bioinform. 2017 Sep 1;18(5):851-869. doi: 10.1093/bib/bbw068.
- Yi Mao, Wenlin Chen, Yixin Chen, Chenyang Lu, Marin Kollef, and Thomas Bailey. (2012) An integrated data mining approach to real-time clinical monitoring and deterioration warning. Proceedings of the 18th ACM SIGKDD international conference on Knowledge discovery and data mining Pages 1140-1148. doi>10.1145/2339530.2339709
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)
December 18, 2017
Primary Completion (ACTUAL)
May 24, 2018
Study Completion (ACTUAL)
May 31, 2018
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (ACTUAL)
December 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 3, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106152-E
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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