NCT03362346

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

November 29, 2017

Last Update Submit

June 3, 2018

Conditions

Keywords

Wavelet transformDeep learning

Outcome Measures

Primary Outcomes (1)

  • Neurological status

    Glasgow coma scale/Mortality

    Discharge out of the intensive care unit, averaged 2 weeks

Study Arms (1)

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.

Device: intracranial pressure monitoring

Interventions

The patients may have either intracranial pressure (ICP) monitor insertion or external ventricular drainage that can be used as ICP monitor.

Also known as: physiological monitoring
Neurocritical patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Age younger than 20 years.
  • Continuous monitoring of intracranial pressure is not feasible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 200, Taiwan

Location

Related Publications (7)

  • Diederik P. Kingma and Jimmy Lei Ba. Adam: A method for stochastic optimization. Conference paper at ICLR 2015.

    BACKGROUND
  • Michael Unser and Akram Aldroubi. (1996 Apr) A review of wavelets in biomedical applications. Proceedings of the IEEE 84(4): 626-638.

    BACKGROUND
  • LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539.

    PMID: 26017442BACKGROUND
  • Christopher Torrence and Gilbert P. Compo. (1998 Jan) A practical guide to wavelet analysis. Bulletin of the American Meteorological Society 79(1):61-78.

    BACKGROUND
  • Theis, Fabian & Meyer-Base, Anke. (2010). Biomedical Signal Analysis - Contemporary Methods and Applications. Biomedical Signal Analysis: Contemporary Methods and Applications.

    BACKGROUND
  • Min S, Lee B, Yoon S. Deep learning in bioinformatics. Brief Bioinform. 2017 Sep 1;18(5):851-869. doi: 10.1093/bib/bbw068.

    PMID: 27473064BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Yi-Hsin Tsai, M.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Neurointensive Care Unit

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 5, 2017

Study Start

December 18, 2017

Primary Completion

May 24, 2018

Study Completion

May 31, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations