← Back to Search

Device

ITPR for Traumatic Brain Injury

Phase 2
Waitlist Available
Led By Edward C Nemergfut, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years of age and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 minutes after device activation & 5 minutes after device turned off
Awards & highlights

Study Summary

This trial is for patients who have a functioning intracranial pressure-monitoring device and are either sedated, intubated, and mechanically ventilated, or are scheduled to undergo an operation or interventional neuroradiological procedure. The ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal rube pressure. The effect of the ITPR on intracranial pressure, cerebral perfusion pressure, and secondary indicators of cardiac performance will be examined.

Who is the study for?
This trial is for adults over 18 with traumatic brain injury who have a device to monitor intracranial pressure and are sedated, intubated, and on mechanical ventilation in the NNICU or scheduled for certain procedures at the University of Virginia. Excluded are those with pneumothorax, uncontrolled bleeding or hypertension, or chronic respiratory diseases.Check my eligibility
What is being tested?
The study tests if using an Intrathoracic Pressure Regulator (ITPR) can lower intracranial pressure and improve blood flow to the brain in patients with altered skull elasticity. It involves changing endotracheal tube pressure (-5 mm Hg or -9 mm Hg) and measuring its effects on brain and heart function.See study design
What are the potential side effects?
Potential side effects may include changes in blood gases due to variations in chest cavity pressure from ITPR use. Specific side effect risks aren't detailed but could relate to impacts on breathing dynamics and cardiovascular function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 minutes after device activation & 5 minutes after device turned off
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 minutes after device activation & 5 minutes after device turned off for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemodynamic variables
Secondary outcome measures
cardiac performance

Trial Design

2Treatment groups
Experimental Treatment
Group I: ITPR -9 & then -5 mm HgExperimental Treatment1 Intervention
the ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal tube pressure (ETP) Each subject will have all measurements recorded at both -5 & -9 mm Hg
Group II: ITPR -5 & then _9 mm HGExperimental Treatment1 Intervention
the ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal tube pressure (ETP) Each subject will have all measurements recorded at both -5 & -9 mm Hg

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,012 Total Patients Enrolled
Edward C Nemergfut, MDPrincipal InvestigatorUniversity of Virginia Anesthesiology

Media Library

Traumatic Brain Injury Research Study Groups: ITPR -5 & then _9 mm HG, ITPR -9 & then -5 mm Hg

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the ITPR -9 & then -5mm Hg treatment sanctioned by the FDA?

"Our team at Power attributed a score of 2 to the safety profile for ITPR -9 & then -5mm Hg due to its status as a Phase 2 trial, which has some preliminary data regarding safety yet lacks efficacy-related evidence."

Answered by AI

Are recruiting efforts still underway for this research project?

"This research endeavour, which was initially posted on May 1 2009 and last updated September 17 2010 is not currently enrolling participants. However, clinicaltrials.gov reports that at this time 310 other trials are actively recruiting volunteers."

Answered by AI
Recent research and studies
~1 spots leftby Apr 2025