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Head Positioning for Intracranial Pressure Due to Brain Bleeds
N/A
Recruiting
Led By Cain Dudek, BS
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every fifteen seconds for twenty minutes.
Awards & highlights
Study Summary
This trial will test how head position affects pressure in the brain of people with brain bleeds.
Who is the study for?
This trial is for adults over 18 with a confirmed subarachnoid hemorrhage who have devices to monitor skull pressure and arterial blood pressure. They must be able to consent or have someone who can. Excluded are those prone while intubated, with severe heart failure, pulmonary hypertension, clinical instability, multiple IV meds for blood pressure, active resuscitation, or serious liver issues.Check my eligibility
What is being tested?
The study tests how different body positions affect intracranial pressure in patients with brain bleeds. Positions include lying flat (supine), semi-reclined sitting up slightly (semi-recumbent), and semi-reclined with legs bent.See study design
What are the potential side effects?
Potential side effects may relate to discomfort from position changes or adverse reactions due to increased intracranial pressure during the trial procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during hospitalization, maximum ten sequential days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospitalization, maximum ten sequential days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cerebral Perfusion Pressure Change, measured in mmHg
Intracranial Pressure Change, measured in mmHg
Response of Intracranial Pressure to Positional Changes During Hospitalization
Secondary outcome measures
Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?
Trial Design
1Treatment groups
Experimental Treatment
Group I: Positional ChangesExperimental Treatment3 Interventions
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.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,827 Total Patients Enrolled
Cain Dudek, BSPrincipal InvestigatorPenn State Hershey Medical Center College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a breathing machine and can be laid face down.My heart's pumping ability is very low.You have had bleeding in the space around your brain, confirmed by specific imaging tests.I have been diagnosed with high blood pressure in the lungs.I can lie flat for 30 minutes and am not on multiple IV meds for blood pressure or being resuscitated.I am 18 years old or older.You have a device that measures pressure inside your head.Patients who need to have their blood pressure constantly monitored.I have cirrhosis or signs of liver failure, such as fluid in the abdomen, swelling, or abnormal blood tests.
Research Study Groups:
This trial has the following groups:- Group 1: Positional Changes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial actively seeking participants at present?
"The clinical trial is currently recruiting individuals, as indicated by the information available on clinicaltrials.gov. It was first published on April 24th 2023 and last updated 10 days later."
Answered by AI
How many people have signed up to join this research project?
"Affirmative. Data available on clinicaltrials.gov confirms that this medical experiment, which was initially posted on April 24th 2023, is actively recruiting volunteers. Approximately 15 participants are required from 1 trial site."
Answered by AI
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