ClinicalTrials.Veeva

Menu

Effects of Head-of-Bed on Intracranial Pressure

Penn State Health logo

Penn State Health

Status

Enrolling

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Treatments

Other: Semi-Recumbent
Other: Supine
Other: Semi-Recumbent with Legs Flexed

Study type

Interventional

Funder types

Other

Identifiers

NCT05604404
STUDY00020509

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Positional Changes
Experimental group
Description:
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.
Treatment:
Other: Semi-Recumbent with Legs Flexed
Other: Supine
Other: Semi-Recumbent

Trial contacts and locations

1

Loading...

Central trial contact

Hazard, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems