Brain InjuryACTION-ICPNCT00571623
Automated Chest Physiotherapy to Improve Outcomes in Neuro
An observational study of Brain Injury and Intracranial Hypertension, run by Duke University at 3 sites in United States.
Trial summary
Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Intracranial Hypertension
- What is being tested?
- Chest Physiotherapy
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Mar 2008
- Phase
- Observational
- 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
Study population: 40 subjects with a neurological diagnosis and current ICP in situ.
Who may be able to join
- documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed
Who cannot join
- spinal cord injury such that CPT is not desired
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University
Durham, North Carolina, 27705
Mission Hospital
Mission Viejo, California, 92691
WakeMed Hospital
Raleigh, North Carolina, 27610
About this study
Official title: Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study
Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.
Read the detailed description
The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.
- The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.
- The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study.
- ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject.
- Conditions
- Brain Injury, Intracranial Hypertension
- Being tested
- Chest Physiotherapy
- Keywords
- Brain Injury, Intracranial hypertension, Human subjects, Nursing care
- Medical subject headings
- Brain Injuries, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest PhysiotherapyOther
10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU
| Study group | Role | What they receive |
|---|---|---|
| 1 | All subjects act as their own contral Receives: Other: Chest Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Nursing Foundation
- Responsible party
- Sponsor
- Investigators
- DaiWai M Olson, Phd RN CCRN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571623
- Sponsor's protocol ID
- Pro00001842
- Acronym
- ACTION-ICP
- Status last verified
- Aug 2008
- First submitted
- 10 Dec 2007
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Elf K, Nilsson P, Enblad P. Outcome after traumatic brain injury improved by an organized secondary insult program and standardized neurointensive care. Crit Care Med. 2002 Sep;30(9):2129-34. doi: 10.1097/00003246-200209000-00029.
PubMed 12352052Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. doi: 10.1016/j.ccell.2004.03.005.
PubMed 15358383Olson DM, Thoyre SM, Turner DA, Bennett S, Graffagnino C. Changes in intracranial pressure associated with chest physiotherapy. Neurocrit Care. 2007;6(2):100-3. doi: 10.1007/s12028-007-0015-y.
PubMed 17522792Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. doi: 10.1097/00044067-200510000-00007.
PubMed 16269895Bader MK, Palmer S. Keeping the brain in the zone. Applying the severe head injury guidelines to practice. Crit Care Nurs Clin North Am. 2000 Dec;12(4):413-27.
PubMed 11855245Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. doi: 10.1097/00044067-200510000-00003.
PubMed 16269891Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. No abstract available.
PubMed 9677936
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Chest Physiotherap to Improve Outcomes in Neurocritical Care: An Intracranial Pressure Study
- ClinicalTrials.gov ID
- NCT00571623
- Acronym / sponsor ID
- ACTION-ICP / Pro00001842
- Conditions
- Brain Injury, Intracranial Hypertension
- Keywords
- Brain Injury, Intracranial hypertension, Human subjects, Nursing care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Neuroscience Nursing Foundation
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Dec 2007 (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.
Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.
Detailed description
The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.
- The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.
- The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study.
- ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Chest PhysiotherapyAll subjects act as their own contral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 subjects with a neurological diagnosis and current ICP in situ.
Key inclusion criteria (1 listed)
- documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed
Key exclusion criteria (1 listed)
- spinal cord injury such that CPT is not desired
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 |
|---|---|---|
| Chest Physiotherapy10-minutes of chest physiotherapy using programmed parameters that are components of the specialty beds used in ICU | Other | 1 |
Primary outcome
Intracranial pressure
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Background: PubMed 12352052Elf K, Nilsson P, Enblad P. Outcome after traumatic brain injury improved by an organized secondary insult program and standardized neurointensive care. Crit Care Med. 2002 Sep;30(9):2129-34. doi: 10.1097/00003246-200209000-00029.
- Background: PubMed 15358383Grap MJ, Munro CL. Preventing ventilator-associated pneumonia: evidence-based care. Crit Care Nurs Clin North Am. 2004 Sep;16(3):349-58, viii. doi: 10.1016/j.ccell.2004.03.005.
- Background: PubMed 17522792Olson DM, Thoyre SM, Turner DA, Bennett S, Graffagnino C. Changes in intracranial pressure associated with chest physiotherapy. Neurocrit Care. 2007;6(2):100-3. doi: 10.1007/s12028-007-0015-y.
- Background: PubMed 16269895Littlejohns L, Bader MK. Prevention of secondary brain injury: targeting technology. AACN Clin Issues. 2005 Oct-Dec;16(4):501-14. doi: 10.1097/00044067-200510000-00007.
- Background: PubMed 11855245Bader MK, Palmer S. Keeping the brain in the zone. Applying the severe head injury guidelines to practice. Crit Care Nurs Clin North Am. 2000 Dec;12(4):413-27.
- Background: PubMed 16269891Olson DM, Graffagnino C. Consciousness, coma, and caring for the brain-injured patient. AACN Clin Issues. 2005 Oct-Dec;16(4):441-55. doi: 10.1097/00044067-200510000-00003.
- Background: PubMed 9677936Arbour R. Aggressive management of intracranial dynamics. Crit Care Nurse. 1998 Jun;18(3):30-40; quiz 41-2. No abstract available.
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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.
DaiWai M Olson, Phd RN CCRN principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Intracranial Hypertension, run by Duke University at 3 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571623, which also lists 7 linked publications.
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 9 Jul 2014.