Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05604404
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Head-of-Bed on Intracranial Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016683', 'term': 'Supine Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial Pressure Change, measured in mmHg', 'timeFrame': 'Measured every fifteen seconds for twenty minutes.'}, {'measure': 'Cerebral Perfusion Pressure Change, measured in mmHg', 'timeFrame': 'Measured every fifteen seconds for twenty minutes.'}, {'measure': 'Response of Intracranial Pressure to Positional Changes During Hospitalization', 'timeFrame': 'During hospitalization, maximum ten sequential days.', 'description': 'The response of intracranial pressure to positional changes will be monitored during hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?', 'timeFrame': 'Measured once per day; for up to ten days.', 'description': 'Transcranial Doppler of Middle Cerebral Artery; Mean Velocity'}, {'measure': 'Do Patients Experiencing Vasospasm Have Similar ICP Responses to Positional Changes?', 'timeFrame': 'Measured every fifteen seconds for twenty minutes.', 'description': 'Intracranial Pressure; measured in mmHg'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemorrhage, Subarachnoid', 'Intracranial Pressure'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'referencesModule': {'references': [{'pmid': '24371827', 'type': 'BACKGROUND', '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.'}, {'pmid': '11425944', 'type': 'BACKGROUND', '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.'}, {'pmid': '31194403', 'type': 'BACKGROUND', 'citation': 'Munakomi S, Das JM. Brain Herniation. 2023 Aug 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542246/'}, {'pmid': '12493115', 'type': 'BACKGROUND', '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.'}, {'pmid': '16436770', 'type': 'BACKGROUND', '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.'}, {'pmid': '25318385', 'type': 'BACKGROUND', '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.'}, {'pmid': '16426476', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with subarachnoid hemorrhage confirmed by CT scan, MRI, or cerebral angiogram\n* Age ≥ 18 years old\n* Patients with intracranial pressure monitoring device\n* Patients with continuous arterial blood pressure monitoring\n* The subject or legally authorized representative must be available and able to consent\n\nExclusion Criteria:\n\n* Intubated patients who are prone\n* Patients with left ventricular ejection fraction \\<20% as evidenced by echocardiogram previously documented at any time in the electronic medical record\n* Patients with a diagnosis of pulmonary hypertension\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT05604404', 'briefTitle': 'Effects of Head-of-Bed on Intracranial Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Response of Intracranial Pressure Based on Head-of-Bed Positioning in Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'STUDY00020509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positional Changes', '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.", 'interventionNames': ['Other: Supine', 'Other: Semi-Recumbent', 'Other: Semi-Recumbent with Legs Flexed']}], 'interventions': [{'name': 'Supine', 'type': 'OTHER', 'description': 'The patient will be positioned supine with head-of-bed at zero degrees.', 'armGroupLabels': ['Positional Changes']}, {'name': 'Semi-Recumbent', 'type': 'OTHER', 'description': 'The patient will be placed in a semi-recumbent position with head-of-bed at thirty degrees.', 'armGroupLabels': ['Positional Changes']}, {'name': 'Semi-Recumbent with Legs Flexed', 'type': 'OTHER', 'description': 'The patient will be placed in a semi- recumbent position with head-of-bed at thirty degrees and legs flexed.', 'armGroupLabels': ['Positional Changes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sprague Hazard, MD', 'role': 'CONTACT', 'phone': '800-243-1455'}], 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'centralContacts': [{'name': 'Hazard, M.D.', 'role': 'CONTACT', 'email': 'shazard@pennstatehealth.psu.edu', 'phone': '717-531-6597'}], 'overallOfficials': [{'name': 'Cain Dudek, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Hershey Medical Center College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology; Director of Neuroanesthesia', 'investigatorFullName': 'Sprague W Hazard III', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}