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Subarachnoid Hemorrhage, AneurysmalNCT05604404

Effects of Head-of-Bed on Intracranial Pressure

A study testing Supine, Semi-Recumbent and Semi-Recumbent with Legs Flexed in people with Subarachnoid Hemorrhage, Aneurysmal, run by Milton S. Hershey Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage, Aneurysmal
What is being tested?
Supine, Semi-Recumbent and Semi-Recumbent with Legs Flexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
24 Apr 2023to 13 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Supine, Semi-Recumbent, Semi-Recumbent with Legs Flexed
Keywords
Hemorrhage, Subarachnoid, Intracranial Pressure
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SupineOther

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

  • Semi-RecumbentOther

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

  • Semi-Recumbent with Legs FlexedOther

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

Study groups in NCT05604404
Study groupRoleWhat they receive
Positional ChangesExperimentalThe 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.
Receives: Other: Supine; Other: Semi-Recumbent; Other: Semi-Recumbent with Legs Flexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial Pressure Change, measured in mmHg

    Measured: Measured every fifteen seconds for twenty minutes.

  2. Cerebral Perfusion Pressure Change, measured in mmHg

    Measured: Measured every fifteen seconds for twenty minutes.

  3. Response of Intracranial Pressure to Positional Changes During Hospitalization

    The response of intracranial pressure to positional changes will be monitored during hospitalization.

    Measured: During hospitalization, maximum ten sequential days.

Secondary outcomes (2)

  1. Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?

    Transcranial Doppler of Middle Cerebral Artery; Mean Velocity

    Measured: Measured once per day; for up to ten days.

  2. Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?

    Intracranial Pressure; measured in mmHg

    Measured: Measured every fifteen seconds for twenty minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2022
  2. Study start24 Apr 2023
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

Why it stopped: PI left the institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05604404
Sponsor's protocol ID
STUDY00020509
Status last verified
Apr 2025
First submitted
26 Oct 2022
Last updated
16 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kung DK, Chalouhi N, Jabbour PM, Starke RM, Dumont AS, Winn HR, Howard MA 3rd, Hasan DM. Cerebral blood flow dynamics and head-of-bed changes in the setting of subarachnoid hemorrhage. Biomed Res Int. 2013;2013:640638. doi: 10.1155/2013/640638. Epub 2013 Nov 25.

    PubMed 24371827

  • Mokri B. The Monro-Kellie hypothesis: applications in CSF volume depletion. Neurology. 2001 Jun 26;56(12):1746-8. doi: 10.1212/wnl.56.12.1746.

    PubMed 11425944

  • Munakomi S, Das JM. Brain Herniation. 2026 Feb 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/

    PubMed 31194403

  • Prunell GF, Mathiesen T, Diemer NH, Svendgaard NA. Experimental subarachnoid hemorrhage: subarachnoid blood volume, mortality rate, neuronal death, cerebral blood flow, and perfusion pressure in three different rat models. Neurosurgery. 2003 Jan;52(1):165-75; discussion 175-6. doi: 10.1097/00006123-200301000-00022.

    PubMed 12493115

  • Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. doi: 10.1056/NEJMra052732. No abstract available.

    PubMed 16436770

  • Zoerle T, Lombardo A, Colombo A, Longhi L, Zanier ER, Rampini P, Stocchetti N. Intracranial pressure after subarachnoid hemorrhage. Crit Care Med. 2015 Jan;43(1):168-76. doi: 10.1097/CCM.0000000000000670.

    PubMed 25318385

  • Schulz-Stubner S, Thiex R. Raising the head-of-bed by 30 degrees reduces ICP and improves CPP without compromising cardiac output in euvolemic patients with traumatic brain injury and subarachnoid haemorrhage: a practice audit. Eur J Anaesthesiol. 2006 Feb;23(2):177-80. doi: 10.1017/S0265021505232118. No abstract available.

    PubMed 16426476

Questions about this trial

What is this clinical trial studying?

A study testing Supine, Semi-Recumbent and Semi-Recumbent with Legs Flexed in people with Subarachnoid Hemorrhage, Aneurysmal, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Pressure Change, measured in mmHg (time frame: Measured every fifteen seconds for twenty minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05604404, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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