Effects of Head-of-Bed on Intracranial Pressure

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604404
• Other study ID #: STUDY00020509
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Milton S. Hershey Medical Center
• Contact: Hazard, M.D.
• Phone: 717-531-6597
• Email: shazard[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

Munakomi S, M Das J. Brain Herniation. 2023 Aug 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure Change, measured in mmHg		Measured every fifteen seconds for twenty minutes.
Primary	Cerebral Perfusion Pressure Change, measured in mmHg		Measured every fifteen seconds for twenty minutes.
Primary	Response of Intracranial Pressure to Positional Changes During Hospitalization	The response of intracranial pressure to positional changes will be monitored during hospitalization.	During hospitalization, maximum ten sequential days.
Secondary	Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?	Transcranial Doppler of Middle Cerebral Artery; Mean Velocity	Measured once per day; for up to ten days.
Secondary	Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?	Intracranial Pressure; measured in mmHg	Measured every fifteen seconds for twenty minutes.