Head InjuryPhase 4NCT01824589
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
A Phase 4 study testing -7 cm H2O ITPR and -12cm H2O ITPR in people with Head Injury, run by Advanced Circulatory Systems.
Trial summary
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Head Injury
- What is being tested?
- -7 cm H2O ITPR and -12cm H2O ITPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥15 years of age
- intubated and mechanically ventilated on a volume controlled mode
- head injury or other intracranial pathology with ICP of ≥15 mmHg
- arterial line in place
- SpO2 ≥95%
- MAP >60
Show all 9Show fewer
- in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
- inclusion presents no significant delays to planned emergent neurosurgery
- prior written informed consent
Who cannot join
- cardiac or pulmonary injury impacting intrathoracic pressure
- confirmed pneumothorax or hemothorax
- PaO2/FiO2 <300
- serious neck injury resulting in neck swelling with jugular venous compression
- evidence of ongoing uncontrolled bleeding
- respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
- congestive heart failure
About this study
Official title: Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
- Conditions
- Head Injury
- Being tested
- -7 cm H2O ITPR, -12cm H2O ITPR
- Keywords
- traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Hepatic Encephalopathy, Hydrocephalus, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-7 cm H2O ITPRDevice
Also called Intrathoracic Pressure Regulator, CirQlator
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.
-12cm H2O ITPRDevice
Also called Intrathoracic Pressure Regulatory, CirQlator
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device Receives: Device: -7 cm H2O ITPR |
| Group B | Active comparator | tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device Receives: Device: -7 cm H2O ITPR |
| Group C | Active comparator | tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device Receives: Device: -12cm H2O ITPR |
| Group D | Active comparator | tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device Receives: Device: -12cm H2O ITPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Pressure (ICP)
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
Measured: 15 minutes after device is activated
Secondary outcomes (3)
Cerebral Perfusion Pressure (CPP)
Measurement of the difference between baseline CPP and CPP at 15 minutes
Measured: 15 minutes after device activation
Lung Compliance
Change in lung compliance following each ITPR treatment compared to baseline.
Measured: baseline and immediately after device removal
Arterial Blood Gases (PaCO2)
Arterial blood gases will be collected.
Measured: 15 minutes after device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Circulatory Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824589
- Sponsor's protocol ID
- ACSI W81XWH-11-1-0542
- Other IDs
- W81XWH-11-1-0542
- Status last verified
- Feb 2015
- First submitted
- 29 Mar 2013
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
- ClinicalTrials.gov ID
- NCT01824589
- Acronym / sponsor ID
- ACSI W81XWH-11-1-0542
- Conditions
- Head Injury
- Keywords
- traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Advanced Circulatory SystemsIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: -7 cm H2O ITPRtidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device |
| Group B | Active comparator | Device: -7 cm H2O ITPRtidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device |
| Group C | Active comparator | Device: -12cm H2O ITPRtidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device |
| Group D | Active comparator | Device: -12cm H2O ITPRtidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- ≥15 years of age
- intubated and mechanically ventilated on a volume controlled mode
- head injury or other intracranial pathology with ICP of ≥15 mmHg
- arterial line in place
- SpO2 ≥95%
Key exclusion criteria (7 listed)
- cardiac or pulmonary injury impacting intrathoracic pressure
- confirmed pneumothorax or hemothorax
- PaO2/FiO2 <300
- serious neck injury resulting in neck swelling with jugular venous compression
- evidence of ongoing uncontrolled bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| -7 cm H2O ITPRAlso: Intrathoracic Pressure Regulator, CirQlatorSingle use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations. | Device | Group A, Group B |
| -12cm H2O ITPRAlso: Intrathoracic Pressure Regulatory, CirQlatorSingle use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations. | Device | Group C, Group D |
Primary outcome
Intracranial Pressure (ICP)
Time frame: 15 minutes after device is activated
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
3 secondary outcomes
Cerebral Perfusion Pressure (CPP)
Time frame: 15 minutes after device activation
Lung Compliance
Time frame: baseline and immediately after device removal
Arterial Blood Gases (PaCO2)
Time frame: 15 minutes after device activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing -7 cm H2O ITPR and -12cm H2O ITPR in people with Head Injury, run by Advanced Circulatory Systems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Pressure (ICP) (time frame: 15 minutes after device is activated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.