Effects of Head-of-Bed on Intracranial Pressure

NCT ID: NCT05604404

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2026-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supine

Intervention Type OTHER

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

Semi-Recumbent

Intervention Type OTHER

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

Semi-Recumbent with Legs Flexed

Intervention Type OTHER

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

Interventions

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Supine

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

Intervention Type OTHER

Semi-Recumbent

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sprague W Hazard III

Assistant Professor of Anesthesiology; Director of Neuroanesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cain Dudek, BS

Role: PRINCIPAL_INVESTIGATOR

Penn State Hershey Medical Center College of Medicine

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hazard, M.D.

Role: CONTACT

717-531-6597

Facility Contacts

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Sprague Hazard, MD

Role: primary

800-243-1455

References

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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.

Reference Type BACKGROUND
PMID: 24371827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11425944 (View on PubMed)

Munakomi S, Das JM. Brain Herniation. 2023 Aug 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/

Reference Type BACKGROUND
PMID: 31194403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12493115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16436770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25318385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16426476 (View on PubMed)

Other Identifiers

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STUDY00020509

Identifier Type: -

Identifier Source: org_study_id

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