Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-28 @ 3:17 PM
Study NCT ID:
NCT01850069
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2013-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial elastance', 'timeFrame': 'Participants will be followed while an arterial line and intracranial pressure monitor is present duing the ICU admission. This is expected to be an average of 5 days.', 'description': 'Intracranial elastance (δP/δV)will be measured by dividing the pulse pressure of an invasive arterial blood pressure by the amplitude of high frequency oscillations in the near infrared (NIR) absorbance waveforms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intracranial hypertension', 'intracranial elastance'], 'conditions': ['Intracranial Hypertension']}, 'referencesModule': {'references': [{'pmid': '17511542', 'type': 'BACKGROUND', 'citation': 'Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Carney NA. Guidelines for the management of severe traumatic brain injury. Methods. J Neurotrauma. 2007;24 Suppl 1:S3-6. doi: 10.1089/neu.2007.9996. No abstract available.'}, {'pmid': '21519957', 'type': 'BACKGROUND', 'citation': 'Rosenberg JB, Shiloh AL, Savel RH, Eisen LA. Non-invasive methods of estimating intracranial pressure. Neurocrit Care. 2011 Dec;15(3):599-608. doi: 10.1007/s12028-011-9545-4.'}, {'pmid': '19286593', 'type': 'BACKGROUND', 'citation': 'Lee JK, Kibler KK, Benni PB, Easley RB, Czosnyka M, Smielewski P, Koehler RC, Shaffner DH, Brady KM. Cerebrovascular reactivity measured by near-infrared spectroscopy. Stroke. 2009 May;40(5):1820-6. doi: 10.1161/STROKEAHA.108.536094. Epub 2009 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy', 'detailedDescription': 'The management of intracranial hypertension requires the presence of an intracranial pressure monitor. We are investigating whether the waveforms obtained from a near infrared spectroscopy device can predict what the intracranial pressure is non-invasively.\n\n* Patients with intracranial hypertension who are intubated and ventilated in the ICU will be recruited\n* we will record there intracranial pressure and systemic arterial pressure\n* recordings from the near infrared device will be recorded and analysed off-line\n* we will correlate the waveform tracings from near infrared spectroscopy and the arterial tracing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU\n\nExclusion Criteria:\n\nLess than 18 years'}, 'identificationModule': {'nctId': 'NCT01850069', 'briefTitle': 'The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)', 'orgStudyIdInfo': {'id': '16714'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intracranial hypertension', 'description': 'Patients with raised intracranial pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Bhiken Naik, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Anesthesiology', 'investigatorFullName': 'Bhiken I. Naik, MD', 'investigatorAffiliation': 'University of Virginia'}}}}