NCT05604404

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 24, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

October 26, 2022

Last Update Submit

April 13, 2026

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Hemorrhage, SubarachnoidIntracranial Pressure

Outcome Measures

Primary Outcomes (3)

  • Intracranial Pressure Change, measured in mmHg

    Measured every fifteen seconds for twenty minutes.

  • Cerebral Perfusion Pressure Change, measured in mmHg

    Measured every fifteen seconds for twenty minutes.

  • 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 Outcomes (2)

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

    Measured once per day; for up to ten days.

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

    Measured every fifteen seconds for twenty minutes.

Study Arms (1)

Positional Changes

EXPERIMENTAL

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.

Other: SupineOther: Semi-RecumbentOther: Semi-Recumbent with Legs Flexed

Interventions

SupineOTHER

The patient will be positioned supine with head-of-bed at zero degrees.

Positional Changes
Semi-RecumbentOTHER

The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.

Positional Changes
Semi-Recumbent with Legs FlexedOTHER

The patient will be placed in a semi- recumbent position with head-of-bed at thirty degrees and legs flexed.

Positional Changes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related 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.

    PMID: 24371827BACKGROUND

  • 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.

    PMID: 11425944BACKGROUND

  • Munakomi S, Das JM. Brain Herniation. 2026 Feb 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/

    PMID: 31194403BACKGROUND

  • 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.

    PMID: 12493115BACKGROUND

  • 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.

    PMID: 16436770BACKGROUND

  • 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.

    PMID: 25318385BACKGROUND

  • 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.

    PMID: 16426476BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cain Dudek, BS

    Penn State Hershey Medical Center College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology; Director of Neuroanesthesia

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 3, 2022

Study Start

April 24, 2023

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

April 16, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)