Head Positioning for Intracranial Pressure Due to Brain Bleeds

Overseen By Hazard, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pulmonary hypertension, Cirrhosis, Clinically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how changing head positions affects intracranial pressure in patients with brain bleeds. Researchers aim to determine if adjusting the bed angle (known as Head-of-Bed Positioning) can effectively manage this pressure. Participants will experience different bed positions while doctors measure pressure changes. Suitable candidates for this trial are adults with a specific type of brain bleed, confirmed by imaging tests, who are being monitored for brain pressure.

As an unphased trial, this study provides patients with a unique opportunity to contribute to understanding innovative care strategies for brain bleeds.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this head positioning technique is safe for patients with brain bleeds?

Research shows that adjusting the head of the bed can help manage intracranial pressure in patients with brain bleeds. Studies indicate that raising the head of the bed to 30 degrees can reduce this pressure effectively. One study noted a 9 mm Hg drop in pressure when the bed was tilted to 30 degrees.

Other research supports that keeping the head elevated not only helps reduce pressure but also lowers the risk of bleeding complications. This suggests that changing the bed's position is generally well-tolerated and could be a safe option for those with brain bleeds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on head positioning for managing intracranial pressure due to brain bleeds because it explores a non-invasive and easily adjustable method that could complement or even enhance current treatments. While standard care often involves medication or surgical interventions to manage intracranial pressure, this approach focuses on how simple positional changes can affect pressure levels. By adjusting the head-of-bed angle and leg position, it offers a potential quick and cost-effective way to stabilize patients without additional drugs or invasive procedures. This method could lead to new insights into managing brain bleeds, making it a promising area of research.

What evidence suggests that head-of-bed positioning is effective for managing intracranial pressure?

Research has shown that changing the head-of-bed (HOB) position can greatly impact brain pressure in patients with brain injuries. In this trial, participants will experience different HOB positions to assess their effects on intracranial pressure. Studies have found that raising the head from lying flat to a 30-degree angle can significantly lower this pressure. For example, one study noted a 9 mm Hg drop in brain pressure at a 30-degree elevation. A review of multiple studies found that raising the HOB to 30° or 45° can reduce brain pressure by an average of 2.40 mm Hg. Importantly, raising the HOB to 30 degrees did not increase brain pressure, making it a potentially effective way to manage pressure in patients with brain bleeds. ^{3 5 6 7 8}

Who Is on the Research Team?

Cain Dudek, BS

Principal Investigator

Penn State Hershey Medical Center College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed subarachnoid hemorrhage who have devices to monitor skull pressure and arterial blood pressure. They must be able to consent or have someone who can. Excluded are those prone while intubated, with severe heart failure, pulmonary hypertension, clinical instability, multiple IV meds for blood pressure, active resuscitation, or serious liver issues.

Inclusion Criteria

You have had bleeding in the space around your brain, confirmed by specific imaging tests.

You have a device that measures pressure inside your head.

Patients who need to have their blood pressure constantly monitored.

Exclusion Criteria

I am on a breathing machine and can be laid face down.

My heart's pumping ability is very low.

I have been diagnosed with high blood pressure in the lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo positional changes to evaluate intracranial pressure response

10 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Head-of-Bed Positioning

Trial Overview The study tests how different body positions affect intracranial pressure in patients with brain bleeds. Positions include lying flat (supine), semi-reclined sitting up slightly (semi-recumbent), and semi-reclined with legs bent.

How Is the Trial Designed?

Group I: Positional Changes Experimental Treatment 3 Interventions

The patient will begin in a supine position with the head-of-bed (HOB) at zero (0) degrees. The patient will remain in this position for five (5) minutes while pressure data is collected every fifteen (15) seconds. Next, the HOB will be adjusted to thirty (30) degrees. The patient will remain in this position for five (5) minutes while pressure data is collected every fifteen (15) seconds. Lastly, the HOB will remain at thirty (30) degrees and the foot-of-bed (FOB) will be adjusted to place the patient's leg in a dependent position. The patient will remain in this position for five (5) minutes while pressure data is collected every fifteen (15) seconds.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

In a study of 23 patients with severe acute brain injury, lowering the head position from 30° to 0° significantly increased intracranial pressure (ICP) by an average of 7.4 mm Hg, indicating a potential risk of elevated ICP in flat positions.

Conversely, brain oxygenation and circulation improved when the head was lowered from 30° to 0°, suggesting that individualized head positioning may be beneficial for optimizing brain oxygenation and blood flow in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Head-of-Bed Posture on Brain Oxygenation in Patients with Acute Brain Injury: A Prospective Cohort Study. Burnol, L., Payen, JF., Francony, G., et al.[2022]

In a study of 18 pediatric patients with severe traumatic brain injury (TBI), the optimal head of bed (HOB) position for minimizing intracranial pressure (ICP) and maximizing cerebral perfusion pressure (CPP) was found to vary, indicating that a standard 30° elevation may not be suitable for all patients.

The research highlighted that individualized HOB positioning is crucial, as some patients showed better outcomes at different angles, including horizontal positioning, emphasizing the need for daily assessment of optimal HOB for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head of bed elevation in pediatric patients with severe traumatic brain injury. Lang, SS., Valeri, A., Zhang, B., et al.[2022]

Elevating the head of the bed to 45° in mechanically ventilated patients significantly reduces mean arterial pressure (MAP) and central venous oxygen saturation (ScvO2), indicating potential hemodynamic instability.

Factors such as the mode of mechanical ventilation and the dose of norepinephrine were found to significantly influence the risk of hypotension during head elevation, suggesting that patients may need to be positioned at a lower angle (20° to 30°) to maintain stability, especially early in their ICU stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the semirecumbent position on hemodynamic status in patients on invasive mechanical ventilation: prospective randomized multivariable analysis. Göcze, I., Strenge, F., Zeman, F., et al.[2021]

Head elevation is a common nursing practice to reduce intracranial pressure (ICP) in patients with neurotrauma, but it can also risk causing intracranial hypertension and reduced blood flow to the brain (cerebral ischemia) due to lower cerebral perfusion pressure (CPP).

The review emphasizes the importance of monitoring both ICP and CPP when determining the optimal head position for individual patients, suggesting that personalized approaches are necessary for effective management of intracranial hemodynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of intracranial hemodynamics in the adult: a research analysis of head positioning and recommendations for clinical practice and future research. Simmons, BJ.[2019]

In a study of 20 acute ischemic stroke patients, lowering the head of the bed from 30 degrees to 0 degrees significantly increased mean flow velocity in the middle cerebral artery, suggesting improved blood flow to the affected brain tissue.

Lowering the head position did not increase resistance to blood flow, and some patients experienced immediate neurological improvement, indicating that adjusting head positioning could be a beneficial intervention in acute stroke management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heads down: flat positioning improves blood flow velocity in acute ischemic stroke. Wojner-Alexander, AW., Garami, Z., Chernyshev, OY., et al.[2016]

In a study of 136 patients, measuring cerebral perfusion pressure (CPP) with the arterial transducer positioned at the tragus resulted in significantly lower values compared to when it was positioned at the phlebostatic axis, regardless of the head-of-bed (HOB) elevation.

This finding suggests that the position of the arterial transducer can influence CPP readings, indicating that careful consideration of measurement techniques is crucial in managing patients at risk for intracranial hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Head-of-Bed Positioning and Transducer Location on Cerebral Perfusion Pressure Measurement. McNett, M., Livesay, S., Yeager, S., et al.[2019]

Current nursing practice typically involves elevating the head of the bed (HOB) to 30 or 45 degrees for patients with cerebral edema, but new guidelines for managing intracranial hypertension suggest that this practice may need to be re-evaluated.

The article aims to critically assess existing research on the effects of HOB elevation on patients with intracranial hypertension and propose updated recommendations based on the latest critical pathway for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positioning and intracranial hypertension: implications of the new critical pathway for nursing practice. Beitel, J.[2016]

Implementing a standardized order for semirecumbent head-of-bed positioning in mechanically ventilated patients significantly increased the average angle of head positioning from 24 degrees to 35 degrees, reducing the risk of ventilator-associated pneumonia (VAP).

Following a provider education program, the percentage of patients positioned at greater than 45 degrees rose from 3% to 29%, demonstrating that both standardized orders and education can effectively maintain improved positioning practices over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of standardized orders and provider education on head-of-bed positioning in mechanically ventilated patients. Helman, DL., Sherner, JH., Fitzpatrick, TM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8312355/

Impact of Head-of-Bed Posture on Brain Oxygenation in ... In patients with traumatic brain injury (TBI), elevating the head from 0° (supine position) to 30° significantly decreased ICP and was ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05604404/effects-of-head-of-bed-on-intracranial-pressure?q=stroke&page=5

Effects of Head-of-Bed on Intracranial Pressure The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.

3. researchgate.net researchgate.net/publication/370229135_A_Meta-analysis_of_the_Clinical_Efficacy_of_the_Head-of-Bed_Elevation_for_Patients_With_Acquired_Brain_Injury?_share=1

A Meta-analysis of the Clinical Efficacy of the Head-of-Bed ... The results showed that, compared with the flat position, HOB elevation of 30° or 45° can significantly reduce ICP (mean difference [MD], -2.40 ...

4. ahajournals.org ahajournals.org/doi/10.1161/hs0202.102376

Effects of Body Position on Intracranial Pressure and ... In 1 episode, there was a marked decrease in ICP of 9 mm Hg at 30° backrest elevation. An increase in ICP with backrest elevation was never noted. Maximal CPP ...

5. vjneurology.com vjneurology.com/zodiac-trial-demonstrates-the-impact-of-head-of-bed-positioning-in-lvo-stroke-care/

ZODIAC trial demonstrates the impact of head-of-bed ... At at a 30-degree HOB, 55% of patients exhibited an increase of ≥2 points on NIHSS, versus 2% in the 0-degree HOB arm (HR 50.5, p<0.001).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041589/

International beliefs and head positioning practices in ... Collectively, these findings suggest that head elevation may in fact be one of the most important first steps in managing hyperacute ICH ...

7. vjneurology.com vjneurology.com/video/7wghrrw8x8w-potential-impact-of-head-positioning-in-intracerebral-hemorrhage/

ISC 2024 | Potential impact of head positioning in ... Prof. Alexandrov aims to advance our understanding of bed positioning effects on the neurological outcomes of ICH patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12126329/

Impact of patient positioning on bleeding rate in stereotactic ... The semi-sitting position during SBB seems to reduce the risk of hemorrhagic complications compared to the supine position.