Study Results
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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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-04-24
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
Supine
The patient will be positioned supine with head-of-bed at zero degrees.
Semi-Recumbent
The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.
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.
Interventions
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Supine
The patient will be positioned supine with head-of-bed at zero degrees.
Semi-Recumbent
The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Sprague W Hazard III
Assistant Professor of Anesthesiology; Director of Neuroanesthesia
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
Countries
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Central Contacts
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Facility Contacts
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Sprague Hazard, MD
Role: primary
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.
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.
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/
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.
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.
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.
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.
Other Identifiers
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STUDY00020509
Identifier Type: -
Identifier Source: org_study_id
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