← 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 5 minutes after device activation & 5 minutes after device turned off

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,011 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

CirculationJournal

Intrathoracic Pressure Regulator During Continuous-chest-compression Advanced Cardiac Resuscitation Improves Vital Organ Perfusion Pressures in a Porcine Model of Cardiac Arrest

Yannopoulos, Demetris, Vinay M. Nadkarni, Scott H. McKnite, Anu Rao, Kurt Kruger, Anja Metzger, David G. Benditt, and Keith G. Lurie. 2005. “Intrathoracic Pressure Regulator During Continuous-chest-compression Advanced Cardiac Resuscitation Improves Vital Organ Perfusion Pressures in a Porcine Model of Cardiac Arrest”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.105.541508.

CirculationJournal

Use of an Inspiratory Impedance Valve Improves Neurologically Intact Survival in a Porcine Model of Ventricular Fibrillation

Lurie, Keith G., Todd Zielinski, Scott McKnite, Tom Aufderheide, and Wolfgang Voelckel. 2002. “Use of an Inspiratory Impedance Valve Improves Neurologically Intact Survival in a Porcine Model of Ventricular Fibrillation”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/hc0102.101391.

ChestJournal

Optimizing Standard Cardiopulmonary Resuscitation with an Inspiratory Impedance Threshold Valve

Lune, Keith G., Katherine A. Mulligan, Scott McKnite, Barry Detloff, Paul Lindstrom, and Karl H. Lindner. 1998. “Optimizing Standard Cardiopulmonary Resuscitation with an Inspiratory Impedance Threshold Valve”. Chest. Elsevier BV. doi:10.1378/chest.113.4.1084.

Critical Care MedicineJournal