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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
Must not have
Hemothorax
Pneumothorax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 minutes after device activation & 5 minutes after device turned off
Awards & highlights

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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have blood in the chest outside the lung.
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I have had a collapsed lung.
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I have a bleeding problem that isn't under control.
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My blood pressure was over 180 at the time of surgery.
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I have a known respiratory disease like COPD.

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
761 Previous Clinical Trials
1,256,018 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
~1 spots leftby Jul 2025
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