Effects of Head-of-Bed on Intracranial Pressure

April 13, 2026 updated by: Sprague W Hazard III, Milton S. Hershey Medical Center

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positional Changes
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.
Other: Supine
The patient will be positioned supine with head-of-bed at zero degrees.
Other: Semi-Recumbent
The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.
Other: Semi-Recumbent with Legs Flexed
The patient will be placed in a semi- recumbent position with head-of-bed at thirty degrees and legs flexed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of Intracranial Pressure to Positional Changes During Hospitalization
Time Frame: During hospitalization, maximum ten sequential days.
The response of intracranial pressure to positional changes will be monitored during hospitalization.
During hospitalization, maximum ten sequential days.
Intracranial Pressure Change, measured in mmHg
Time Frame: Measured every fifteen seconds for twenty minutes.
Measured every fifteen seconds for twenty minutes.
Cerebral Perfusion Pressure Change, measured in mmHg
Time Frame: Measured every fifteen seconds for twenty minutes.
Measured every fifteen seconds for twenty minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Time Frame: Measured once per day; for up to ten days.
Transcranial Doppler of Middle Cerebral Artery; Mean Velocity
Measured once per day; for up to ten days.
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Time Frame: Measured every fifteen seconds for twenty minutes.
Intracranial Pressure; measured in mmHg
Measured every fifteen seconds for twenty minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Cain Dudek, BS, Penn State Hershey Medical Center College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Actual)

April 13, 2026

Study Completion (Actual)

April 13, 2026

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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