Cerebral HypoperfusionEarly Phase 1NCT03285971
Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
A Early Phase 1 study testing Electronic CPP pager alert in people with Cerebral Hypoperfusion, run by University of Michigan at 1 site in United States.
Trial summary
Across broad surgical populations, cerebral hypoperfusion is associated with increased mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be maintained greater than 60 mmHg in high-risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hypoperfusion
- What is being tested?
- Electronic CPP pager alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 11 Dec 2021
- Phase
- Early Phase 1
- 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
- Adult (≥18 years old) surgical patients
- Intracranial pathology requiring intracranial pressure (ICP) monitoring
Who cannot join
- Intracranial aneurysm surgery
- Cases with pressures monitored from a lumbar drain
- Cardiac surgery cases
- Enrolled in conflicting study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109
About this study
Across broad surgical populations, cerebral hypoperfusion is associated with increased mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia. Though several lines of investigation have focused on optimal cerebrovascular management in the intensive care unit and cardiac surgery settings, much less focus has been placed on cerebrovascular management during non-cardiac surgery.
Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in neurosurgical and trauma surgery settings, though the relationship between reduced intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low intraoperative CPP could be prevented have not been thoroughly investigated, which represents the first required step prior to studying the relationship between intraoperative CPP and clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will increase intraoperative CPP compared to standard of care.
Read the detailed description
This will be a single-center study taking place at the University of Michigan Health System, Ann Arbor, MI. The study has been approved by the University of Michigan Medical School Institutional Review Board (IRBMED).
Automated pager alert protocols have been previously published from the investigators' department, and this alerting system is used for operational purposes on a daily basis. Surgical patients will be automatically screened using a designed script from the anesthesia information management system (Centricity, Wishahaka, WI).
The script will screen for active surgical patients with intracranial pressure (ICP) data recording in our hospital's non-cardiac operating rooms. When these data are captured, an automated enrollment process will occur if the following electronic charting criteria are met:
- Age ≥ 18 years old
- Case identified as a general anesthetic
- Non-intracranial aneurysm surgery
- Non-pregnant patient
After "anesthetic induction end" time is documented within the case, the alerting system will turn on after a 10-minute grace period. The alerting system will then retroactively measure median CPP values over 5-minute epochs, and if median CPP is < 60 mmHg, the following alphanumeric pager alert will be delivered:
"Patient: LAST NAME, FIRST NAME, OR(N), has a cerebral perfusion pressure < 60 mmHg. Disregard alert for intracranial aneurysm cases or if patient is pregnant."
This alert will be delivered twice total (if criteria are met). The aim of the pager alerts will be to relay information regarding cerebral ischemia risk between when CPP decreases below 60 mmHg. Final clinical decision-making, however, will be left to the anesthesia team. The pager alerts will not otherwise compel action, and no other recommendations will be made.
- Conditions
- Cerebral Hypoperfusion
- Being tested
- Electronic CPP pager alert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CPP pager alertOther
Also called Alerting system
Anesthesia providers will receive a pager alert when CPP decreases beow 60 mmHG (median value over 5-minute epochs)
| Study group | Role | What they receive |
|---|---|---|
| CPP Alert Group | Experimental | Device: Electronic CPP pager alert anesthesia providers will receive a pager alert when CPP decreases below 60 mmHg (median value over 5-minute epochs) Receives: Other: Electronic CPP pager alert |
| Control | No intervention | This arm will not receive the automated pager alerts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cerebral Perfusion Pressure (CPP, mmHg)
Measured: Assessed intraoperatively for the duration of the CPP monitoring period
Secondary outcomes (7)
Mortality (incidence, %)
Measured: Within 30 days of surgery
Postoperative Stroke (incidence, %)
Measured: Within 30 days of surgery
Myocardial Infarction (incidence, %)
Measured: Within 30 days of surgery
Congestive Heart Failure (incidence, %)
Measured: Within 30 days of surgery
Cardiac Dysrythmias (incidence, %)
New onset of any of the following: supraventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrilation, ventricular tachycardia, heart block requiring pacing
Measured: Within 30 days of surgery
Acute Respiratory Distress Syndrome, ARDS (incidence, %)
Measured: Within 30 days of surgery
Acute Kidney Injury, AKI (incidence, %)
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start25 Sep 2017
- Primary completion11 Dec 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral HypoperfusionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Vlisides, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285971
- Sponsor's protocol ID
- HUM117828
- Status last verified
- Oct 2022
- First submitted
- 14 Sep 2017
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available.
PubMed 17511547Moore LE, Sharifpour M, Shanks A, Kheterpal S, Tremper KK, Mashour GA. Cerebral perfusion pressure below 60 mm Hg is common in the intraoperative setting. J Neurosurg Anesthesiol. 2012 Jan;24(1):58-62. doi: 10.1097/ANA.0b013e31822b4f05.
PubMed 21862931Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.
PubMed 19891771Mashour GA, Shanks A, Tremper KK, Kheterpal S, Turner CR, Ramachandran SK, Picton P, Schueller C, Morris M, Vandervest JC, Lin N, Avidan MS. Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial. Anesthesiology. 2012 Oct;117(4):717-25. doi: 10.1097/ALN.0b013e31826904a6.
PubMed 22990178Blum JM, Stentz MJ, Maile MD, Jewell E, Raghavendran K, Engoren M, Ehrenfeld JM. Automated alerting and recommendations for the management of patients with preexisting hypoxia and potential acute lung injury: a pilot study. Anesthesiology. 2013 Aug;119(2):295-302. doi: 10.1097/ALN.0b013e3182987af4.
PubMed 23681144
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
- ClinicalTrials.gov ID
- NCT03285971
- Acronym / sponsor ID
- HUM117828
- Conditions
- Cerebral Hypoperfusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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.
Across broad surgical populations, cerebral hypoperfusion is associated with increased mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia. Though several lines of investigation have focused on optimal cerebrovascular management in the intensive care unit and cardiac surgery settings, much less focus has been placed on cerebrovascular management during non-cardiac surgery.
Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in neurosurgical and trauma surgery settings, though the relationship between reduced intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low intraoperative CPP could be prevented have not been thoroughly investigated, which represents the first required step prior to studying the relationship between intraoperative CPP and clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will increase intraoperative CPP compared to standard of care.
Detailed description
This will be a single-center study taking place at the University of Michigan Health System, Ann Arbor, MI. The study has been approved by the University of Michigan Medical School Institutional Review Board (IRBMED).
Automated pager alert protocols have been previously published from the investigators' department, and this alerting system is used for operational purposes on a daily basis. Surgical patients will be automatically screened using a designed script from the anesthesia information management system (Centricity, Wishahaka, WI).
The script will screen for active surgical patients with intracranial pressure (ICP) data recording in our hospital's non-cardiac operating rooms. When these data are captured, an automated enrollment process will occur if the following electronic charting criteria are met:
- Age ≥ 18 years old
- Case identified as a general anesthetic
- Non-intracranial aneurysm surgery
- Non-pregnant patient
After "anesthetic induction end" time is documented within the case, the alerting system will turn on after a 10-minute grace period. The alerting system will then retroactively measure median CPP values over 5-minute epochs, and if median CPP is < 60 mmHg, the following alphanumeric pager alert will be delivered:
"Patient: LAST NAME, FIRST NAME, OR(N), has a cerebral perfusion pressure < 60 mmHg. Disregard alert for intracranial aneurysm cases or if patient is pregnant."
This alert will be delivered twice total (if criteria are met). The aim of the pager alerts will be to relay information regarding cerebral ischemia risk between when CPP decreases below 60 mmHg. Final clinical decision-making, however, will be left to the anesthesia team. The pager alerts will not otherwise compel action, and no other recommendations will be made.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPP Alert Group | Experimental | Other: Electronic CPP pager alertDevice: Electronic CPP pager alert anesthesia providers will receive a pager alert when CPP decreases below 60 mmHg (median value over 5-minute epochs) |
| Control | No intervention | –This arm will not receive the automated pager alerts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥18 years old) surgical patients
- Intracranial pathology requiring intracranial pressure (ICP) monitoring
Key exclusion criteria (5 listed)
- Intracranial aneurysm surgery
- Cases with pressures monitored from a lumbar drain
- Cardiac surgery cases
- Enrolled in conflicting study
- Pregnancy
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 |
|---|---|---|
| Electronic CPP pager alertAlso: Alerting systemAnesthesia providers will receive a pager alert when CPP decreases beow 60 mmHG (median value over 5-minute epochs) | Other | CPP Alert Group |
Primary outcome
Mean Cerebral Perfusion Pressure (CPP, mmHg)
Time frame: Assessed intraoperatively for the duration of the CPP monitoring period
7 secondary outcomes
Mortality (incidence, %)
Time frame: Within 30 days of surgery
Postoperative Stroke (incidence, %)
Time frame: Within 30 days of surgery
Myocardial Infarction (incidence, %)
Time frame: Within 30 days of surgery
Congestive Heart Failure (incidence, %)
Time frame: Within 30 days of surgery
Cardiac Dysrythmias (incidence, %)
Time frame: Within 30 days of surgery
Acute Respiratory Distress Syndrome, ARDS (incidence, %)
Time frame: Within 30 days of surgery
Acute Kidney Injury, AKI (incidence, %)
Time frame: Within 30 days of surgery
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 12 Oct 2022.
- Background: PubMed 17511547Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available.
- Background: PubMed 21862931Moore LE, Sharifpour M, Shanks A, Kheterpal S, Tremper KK, Mashour GA. Cerebral perfusion pressure below 60 mm Hg is common in the intraoperative setting. J Neurosurg Anesthesiol. 2012 Jan;24(1):58-62. doi: 10.1097/ANA.0b013e31822b4f05.
- Background: PubMed 19891771Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.
- Background: PubMed 22990178Mashour GA, Shanks A, Tremper KK, Kheterpal S, Turner CR, Ramachandran SK, Picton P, Schueller C, Morris M, Vandervest JC, Lin N, Avidan MS. Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial. Anesthesiology. 2012 Oct;117(4):717-25. doi: 10.1097/ALN.0b013e31826904a6.
- Background: PubMed 23681144Blum JM, Stentz MJ, Maile MD, Jewell E, Raghavendran K, Engoren M, Ehrenfeld JM. Automated alerting and recommendations for the management of patients with preexisting hypoxia and potential acute lung injury: a pilot study. Anesthesiology. 2013 Aug;119(2):295-302. doi: 10.1097/ALN.0b013e3182987af4.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electronic CPP pager alert in people with Cerebral Hypoperfusion, run by University of Michigan 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 2 inclusion and 5 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 12 Oct 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean Cerebral Perfusion Pressure (CPP, mmHg) (time frame: Assessed intraoperatively for the duration of the CPP monitoring period). 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 NCT03285971, which also lists 5 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 12 Oct 2022.