Back to resultsEffects of Head-of-Bed on Intracranial Pressure
Primary Purpose
Subarachnoid Hemorrhage, Aneurysmal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supine
Semi-Recumbent
Semi-Recumbent with Legs Flexed
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Hemorrhage, Subarachnoid, Intracranial Pressure
Eligibility Criteria
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.
Sites / Locations
- Penn State Milton S. Hershey Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Positional Changes
Arm Description
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.
Outcomes
Primary Outcome Measures
Intracranial Pressure Change, measured in mmHg
Cerebral Perfusion Pressure Change, measured in mmHg
Response of Intracranial Pressure to Positional Changes During Hospitalization
The response of intracranial pressure to positional changes will be monitored during hospitalization.
Secondary Outcome Measures
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Transcranial Doppler of Middle Cerebral Artery; Mean Velocity
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Intracranial Pressure; measured in mmHg
Full Information
NCT ID
NCT05604404
First Posted
October 26, 2022
Last Updated
May 15, 2023
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05604404
Brief Title
Effects of Head-of-Bed on Intracranial Pressure
Official Title
Response of Intracranial Pressure Based on Head-of-Bed Positioning in Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal
Keywords
Hemorrhage, Subarachnoid, Intracranial Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positional Changes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supine
Intervention Description
The patient will be positioned supine with head-of-bed at zero degrees.
Intervention Type
Other
Intervention Name(s)
Semi-Recumbent
Intervention Description
The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.
Intervention Type
Other
Intervention Name(s)
Semi-Recumbent with Legs Flexed
Intervention Description
The patient will be placed in a semi- recumbent position with head-of-bed at thirty degrees and legs flexed.
Primary Outcome Measure Information:
Title
Intracranial Pressure Change, measured in mmHg
Time Frame
Measured every fifteen seconds for twenty minutes.
Title
Cerebral Perfusion Pressure Change, measured in mmHg
Time Frame
Measured every fifteen seconds for twenty minutes.
Title
Response of Intracranial Pressure to Positional Changes During Hospitalization
Description
The response of intracranial pressure to positional changes will be monitored during hospitalization.
Time Frame
During hospitalization, maximum ten sequential days.
Secondary Outcome Measure Information:
Title
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Description
Transcranial Doppler of Middle Cerebral Artery; Mean Velocity
Time Frame
Measured once per day; for up to ten days.
Title
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Description
Intracranial Pressure; measured in mmHg
Time Frame
Measured every fifteen seconds for twenty minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazard, M.D.
Phone
717-531-6597
Email
shazard@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cain Dudek, BS
Organizational Affiliation
Penn State Hershey Medical Center College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sprague Hazard, MD
Phone
800-243-1455
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24371827
Citation
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.
Results Reference
background
PubMed Identifier
11425944
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.
Results Reference
background
PubMed Identifier
31194403
Citation
Munakomi S, M Das J. Brain Herniation. 2023 Aug 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/
Results Reference
background
PubMed Identifier
12493115
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.
Results Reference
background
PubMed Identifier
16436770
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.
Results Reference
background
PubMed Identifier
25318385
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.
Results Reference
background
PubMed Identifier
16426476
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.
Results Reference
background
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Effects of Head-of-Bed on Intracranial Pressure
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