Head InjuryNCT01824576
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
A study testing ITPR in people with Head Injury and Intracranial Pathology, run by Advanced Circulatory Systems at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
- What is being tested?
- ITPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Nov 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- intubated and mechanically ventilated on a volume controlled mode
- head injury or other intracranial pathology and compromised cerebral perfusion
- arterial line in place or alternative with continuous pressure monitoring
- SpO2 ≥90%
- mean arterial pressure >55
Show all 9Show fewer
- admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
- inclusion presents no significant delays to planned emergent neurosurgery
- prior written informed consent
Who cannot join
- cardiac or pulmonary injury
- confirmed pneumothorax or hemothorax
- 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
- marked hypertension at time of device use defined as systolic blood pressure >180 mmHg
- congestive heart failure
- women with positive serum or urine pregnancy test or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore
Baltimore, Maryland
Denver
Denver, Colorado
About this study
Official title: Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.
- Being tested
- ITPR
- Keywords
- ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITPRDevice
Also called Intrathoracic Pressure Regulator, CirQlator
Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.
| Study group | Role | What they receive |
|---|---|---|
| ITPR | Experimental | Use of the ITPR for 120 minutes. Receives: Device: ITPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Change from average baseline CPP compared with the average CPP during use of the ITPR.
Measured: During 120 minutes of device use
Secondary outcomes (8)
Change From Baseline in Systolic Blood Pressure (SBP)
Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to15 minutes following device use
Change From Baseline in PaCO2
PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.
Measured: baseline and 15 minutes after device activation
Change From Baseline in Diastolic Blood Pressure (DBP)
Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to 15 minutes following device use
Change From Baseline in Mean Arterial Pressure (MAP)
Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to 15 minutes following device use
Change From Baseline in Heart Rate (HR)
Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to 15 minutes following device use
Change From Baseline in Pulse Pressure (PP)
Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to 15 minutes following device use
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR
Measured: baseline to 15 minutes following device use
Change From Baseline in Oxygen Saturation (SpO2)
Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR
Measured: basseline to 15 minutes following device use
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 startApr 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Enrollment was slower than anticipated.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Circulatory Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824576
- Sponsor's protocol ID
- ACSI 5R44NS054372
- Other IDs
- 5R44NS054372
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2013
- Last updated
- 27 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology
- ClinicalTrials.gov ID
- NCT01824576
- Acronym / sponsor ID
- ACSI 5R44NS054372
- Keywords
- ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was slower than anticipated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Advanced Circulatory SystemsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 27 Sep 2017
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 the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITPR | Experimental | Device: ITPRUse of the ITPR for 120 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years of age
- intubated and mechanically ventilated on a volume controlled mode
- head injury or other intracranial pathology and compromised cerebral perfusion
- arterial line in place or alternative with continuous pressure monitoring
- SpO2 ≥90%
Key exclusion criteria (8 listed)
- cardiac or pulmonary injury
- confirmed pneumothorax or hemothorax
- 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
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 |
|---|---|---|
| ITPRAlso: Intrathoracic Pressure Regulator, CirQlatorSingle use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations. | Device | ITPR |
Primary outcome
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Time frame: During 120 minutes of device use
Change from average baseline CPP compared with the average CPP during use of the ITPR.
8 secondary outcomes
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: baseline to15 minutes following device use
Change From Baseline in PaCO2
Time frame: baseline and 15 minutes after device activation
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: baseline to 15 minutes following device use
Change From Baseline in Mean Arterial Pressure (MAP)
Time frame: baseline to 15 minutes following device use
Change From Baseline in Heart Rate (HR)
Time frame: baseline to 15 minutes following device use
Change From Baseline in Pulse Pressure (PP)
Time frame: baseline to 15 minutes following device use
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
Time frame: baseline to 15 minutes following device use
Change From Baseline in Oxygen Saturation (SpO2)
Time frame: basseline to 15 minutes following device use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITPR in people with Head Injury and Intracranial Pathology, run by Advanced Circulatory Systems at 2 sites in United States.
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 8 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 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2017). 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?
Change From Baseline in Cerebral Perfusion Pressure (CPP) (time frame: During 120 minutes of device use). 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 27 Sep 2017.