NCT01448681

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:

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 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

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

7.9 years

First QC Date

October 5, 2011

Last Update Submit

September 26, 2019

Conditions

Intracranial HypertensionElevated ICP (Intracranial Pressure)

Keywords

Intracranial HypertensionElevated ICP (Intracranial Pressure)

Outcome Measures

Primary Outcomes (1)

  • Algorithm development

    Developing algorithms relating data to intracranial pressure.

    24 months

Study Arms (1)

SICU patients with ICP

Surgical intensive care unit patients with elevated intracranial pressure

Other: No Interventions

Interventions

No InterventionsOTHER
SICU patients with ICP

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical intensive care unit patients

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Steven Moulton, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

US(1)