Intracranial PressureNCT00279097
Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation
A study testing High Frequency Chest Wall Oscillation in people with Intracranial Pressure, run by Hill-Rom at 1 site in United States.
Trial summary
The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- High Frequency Chest Wall Oscillation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
- On ventilator
- Arterial line in place
- Age equal to or greater than 18
- Admitted to neurotrauma intensive care unit (ICU)
Who cannot join
- Inability to obtain informed consent
- Unstable spinal cord injury
- ICP > 20 mmHg sustained for > 5 minutes
- Hemodynamic instability within the prior 12 hours
- Active hemoptysis
- Hemothorax
Show all 10Show fewer
- New onset, unstable arrhythmia
- Enrollment in another interventional study
- Aneurysm that has not been clipped or coiled
- Coagulopathic head injury subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Houston/Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients
The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.
Read the detailed description
This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.
- Conditions
- Intracranial Pressure
- Being tested
- High Frequency Chest Wall Oscillation
- Keywords
- Intracranial pressure, High Frequency Chest Wall Oscillation, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Chest Wall OscillationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure
SpO2
Heart rate
Mean arterial pressure (MAP)
Arterial blood gases (ABGs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert L Levine, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279097
- Sponsor's protocol ID
- CR-0038
- Status last verified
- Nov 2006
- First submitted
- 17 Jan 2006
- Last updated
- 16 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT00279097
- Acronym / sponsor ID
- CR-0038
- Conditions
- Intracranial Pressure
- Keywords
- Intracranial pressure, High Frequency Chest Wall Oscillation, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Sep 2006
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
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 evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.
Detailed description
This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
- On ventilator
- Arterial line in place
- Age equal to or greater than 18
- Admitted to neurotrauma intensive care unit (ICU)
Key exclusion criteria (10 listed)
- Inability to obtain informed consent
- Unstable spinal cord injury
- ICP > 20 mmHg sustained for > 5 minutes
- Hemodynamic instability within the prior 12 hours
- Active hemoptysis
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 |
|---|---|---|
| High Frequency Chest Wall Oscillation | Device | – |
Primary outcome
Intracranial pressure
SpO2
Heart rate
Mean arterial pressure (MAP)
Arterial blood gases (ABGs)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2006.
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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.
Robert L Levine, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Chest Wall Oscillation in people with Intracranial Pressure, run by Hill-Rom at 1 site 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 5 inclusion and 10 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 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early. Results are not available in the source record.
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. The study lists 5 primary outcomes in all. 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 Nov 2006.