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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured once per day; for up to ten days.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a breathing machine and can be laid face down.

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My heart's pumping ability is very low.

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I have been diagnosed with high blood pressure in the lungs.

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I have cirrhosis or signs of liver failure, such as fluid in the abdomen, swelling, or abnormal blood tests.

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I can lie flat for 30 minutes and am not on multiple IV meds for blood pressure or being resuscitated.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization, maximum ten sequential days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response of Intracranial Pressure to Positional Changes During Hospitalization

Secondary study objectives

Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met