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Effects of Head-of-Bed on Intracranial Pressure

Response of Intracranial Pressure Based on Head-of-Bed Positioning in Aneurysmal Subarachnoid Hemorrhage

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05604404
Enrollment
15
Registered
2022-11-03
Start date
2023-04-24
Completion date
2026-03-31
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Hemorrhage, Subarachnoid, Intracranial Pressure

Brief summary

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

Detailed 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.

Interventions

OTHERSupine

The patient will be positioned supine with head-of-bed at zero degrees.

The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.

OTHERSemi-Recumbent with Legs Flexed

The patient will be placed in a semi- recumbent position with head-of-bed at thirty degrees and legs flexed.

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intracranial Pressure Change, measured in mmHgMeasured every fifteen seconds for twenty minutes.
Cerebral Perfusion Pressure Change, measured in mmHgMeasured every fifteen seconds for twenty minutes.
Response of Intracranial Pressure to Positional Changes During HospitalizationDuring hospitalization, maximum ten sequential days.The response of intracranial pressure to positional changes will be monitored during hospitalization.

Secondary

MeasureTime frameDescription
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?Measured once per day; for up to ten days.Transcranial Doppler of Middle Cerebral Artery; Mean Velocity

Countries

United States

Contacts

Primary ContactHazard, M.D.
shazard@pennstatehealth.psu.edu717-531-6597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026