Effects of Head-of-Bed on Intracranial Pressure

Last updated: April 29, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Hemorrhage

Treatment

Semi-Recumbent with Legs Flexed

Supine

Semi-Recumbent

Clinical Study ID

NCT05604404
STUDY00020509
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with subarachnoid hemorrhage confirmed by CT scan, MRI, or cerebralangiogram

  • 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 toconsent

Exclusion

Exclusion Criteria:

  • Intubated patients who are prone

  • Patients with left ventricular ejection fraction <20% as evidenced by echocardiogrampreviously 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 ofliver failure will be assessed by the presence of ascites, edema, abnormal labvalues including low albumin, elevated PTT, elevated PT, elevated INR, or elevatedbilirubin 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 toincrease blood pressure, or patients who are actively undergoing resuscitation.

Study Design

Total Participants: 15
Treatment Group(s): 3
Primary Treatment: Semi-Recumbent with Legs Flexed
Phase:
Study Start date:
April 24, 2023
Estimated Completion Date:
March 31, 2026

Study Description

The optimal positioning of the head-of-bed (HOB) has remained controversial in the neurosurgical field. Very limited data exists outlining the effects of HOB positioning in subarachnoid hemorrhage (SAH) patients. One study by Schulz-Stubner and Thiex assess the effects of HOB positioning in SAH and traumatic brain injury (TBI) patients. While this study offers some valuable insight into the changes in cerebral hemodynamics seen when the HOB changes, it congregates data from two very different pathologies. This could potentially misrepresent the true effects patients experience. A study by Kung et al. assesses cerebral blood flow dynamics and HOB changes in the setting of SAH but does not evaluate the effects on intracranial pressure (ICP) (Kung, et al., 2013). There appear to be no studies which evaluate the effect of HOB positioning on ICP in patients with SAH. No current data exists to determine if dependent leg positioning would help to further lower ICP. Theoretically, placing a patient's legs in a dependent position would lead to increased venous pooling of blood in the legs which might translate to lower ICP.

Connect with a study center

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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