Evaluating how head position affects pressure in the skull for patients with brain bleeds
Response of Intracranial Pressure Based on Head-of-Bed Positioning in Aneurysmal Subarachnoid Hemorrhage
This study is testing how different ways of positioning the head can affect pressure inside the skull for patients with brain bleeds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05604404 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of different head-of-bed (HOB) positions on intracranial pressure (ICP) in patients suffering from subarachnoid hemorrhage (SAH). It addresses a gap in existing research by focusing specifically on the effects of HOB positioning on ICP, which has not been thoroughly investigated in this patient population. The study will involve patients with confirmed SAH who have ICP monitoring devices, and will compare outcomes across various positions including supine, semi-recumbent, and semi-recumbent with legs flexed. The hypothesis is that certain positions may help lower ICP by promoting venous pooling in the legs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of subarachnoid hemorrhage and who have an intracranial pressure monitoring device.
Not a fit: Patients who are intubated and in a prone position, or those with severe cardiac or liver conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with subarachnoid hemorrhage, potentially reducing intracranial pressure and associated complications.
How similar studies have performed: While some studies have explored head positioning in related conditions, there is a lack of focused research on its effects on intracranial pressure specifically in subarachnoid hemorrhage patients, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with subarachnoid hemorrhage confirmed by CT scan, MRI, or cerebral angiogram * Age ≥ 18 years old * Patients with intracranial pressure monitoring device * Patients with continuous arterial blood pressure monitoring * The subject or legally authorized representative must be available and able to consent Exclusion Criteria: * Intubated patients who are prone * Patients with left ventricular ejection fraction \<20% as evidenced by echocardiogram previously documented at any time in the electronic medical record * Patients with a diagnosis of pulmonary hypertension * Patients with a diagnosis of cirrhosis and/or evidence of liver failure. Evidence of liver failure will be assessed by the presence of ascites, edema, abnormal lab values including low albumin, elevated PTT, elevated PT, elevated INR, or elevated bilirubin without another etiology, or MELD score \>8. * Patients who are clinically unstable defined as those who are unable to lie flat for 30 minutes for any reason, patients on more than one continuous IV medications to increase blood pressure, or patients who are actively undergoing resuscitation.
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Cain Dudek, BS — Penn State Hershey Medical Center College of Medicine
- Study coordinator: Hazard, M.D.
- Email: shazard@pennstatehealth.psu.edu
- Phone: 717-531-6597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.