15 Participants Needed

Head Positioning for Intracranial Pressure Due to Brain Bleeds

HM
Overseen ByHazard, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with 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 data supports the idea that Head Positioning for Intracranial Pressure Due to Brain Bleeds is an effective treatment?

The available research shows that elevating the head of the bed is a common practice for managing intracranial pressure in patients with brain injuries. For example, one study highlights that this position is standard for patients with severe traumatic brain injury, as it may help reduce pressure in the brain by improving blood flow and drainage. Another study indicates that while head elevation is standard, its effects on brain oxygen levels and circulation are still being explored. Overall, the research suggests that head positioning is widely used and believed to help manage brain pressure, although more data is needed to fully understand its benefits.12345

What safety data exists for head positioning in managing intracranial pressure?

The safety data for head positioning, including head-of-bed elevation, in managing intracranial pressure is mixed. Studies indicate that elevating the head of the bed can reduce intracranial pressure, which is beneficial for patients with cerebral edema or at risk of intracranial hypertension. However, there are concerns that it may also decrease cerebral perfusion pressure, potentially leading to cerebral ischemia. The optimal head positioning should be individualized, taking into account both intracranial pressure and cerebral perfusion pressure measurements. Further research is needed to refine these practices and ensure patient safety.24678

Is head positioning a promising treatment for managing intracranial pressure due to brain bleeds?

Yes, head positioning is a promising treatment for managing intracranial pressure from brain bleeds. Elevating the head of the bed can help reduce pressure in the brain by improving blood flow and oxygenation. This method is commonly used in patients with brain injuries to help manage pressure and improve recovery.12345

Research Team

CD

Cain Dudek, BS

Principal Investigator

Penn State Hershey Medical Center College of Medicine

Eligibility Criteria

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.
I am 18 years old or older.
You have a device that measures pressure inside your head.
See 2 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Head-of-Bed Positioning
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Positional ChangesExperimental Treatment3 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Findings from Research

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.
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.
The Impact of Head-of-Bed Positioning and Transducer Location on Cerebral Perfusion Pressure Measurement.McNett, M., Livesay, S., Yeager, S., et al.[2019]
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.
Head of bed elevation in pediatric patients with severe traumatic brain injury.Lang, SS., Valeri, A., Zhang, B., et al.[2022]

References

Heads down: flat positioning improves blood flow velocity in acute ischemic stroke. [2016]
The Impact of Head-of-Bed Positioning and Transducer Location on Cerebral Perfusion Pressure Measurement. [2019]
Head of bed elevation in pediatric patients with severe traumatic brain injury. [2022]
Effect of standardized orders and provider education on head-of-bed positioning in mechanically ventilated patients. [2019]
Impact of Head-of-Bed Posture on Brain Oxygenation in Patients with Acute Brain Injury: A Prospective Cohort Study. [2022]
The effects of the semirecumbent position on hemodynamic status in patients on invasive mechanical ventilation: prospective randomized multivariable analysis. [2021]
Positioning and intracranial hypertension: implications of the new critical pathway for nursing practice. [2016]
Management of intracranial hemodynamics in the adult: a research analysis of head positioning and recommendations for clinical practice and future research. [2019]