A Continuous, Non-Invasive, Real-time Method for Estimati... | NCT01448681

Studies
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

NCT01448681

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Sep 30, 2019Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Intracranial Hypertension
Elevated ICP (Intracranial Pressure)

Interventions

No Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Oct 5, 2011

First Submission Date that Met QC Criteria

Oct 5, 2011

First Posted Date

Oct 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2019

Last Update Posted Date

Sep 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:

Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
Predict and anticipate changes in ICP for preemptive management purposes.
Analyze characteristics of changes in ICP after treatment failure.
Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
Test the resulting models in real time.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SICU patients with ICP		Surgical intensive care unit patients with elevated intracranial pressure	Other: No Interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Interventions	Other		SICU patients with ICP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Algorithm development	Developing algorithms relating data to intracranial pressure.	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5
age 18-89 years
health care provider indicating the need for hyperosmolar therapy for elevated ICP

Exclusion Criteria:

pregnancy
incarceration
brain death (GCS 3 with fixed, dilated pupils)
life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Surgical intensive care unit patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Moulton, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health Medical Center		Denver	Colorado	80204	United States

Condition Browse Module

MeSH Terms

ID	Term
D019586	Intracranial Hypertension

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided