Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT02545803
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2015-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2015-09-08', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The association between HFPV and cerebral oxygen saturation', 'timeFrame': 'Two hours before switch to HFPV until 24 hours after the switch to HFPV', 'description': 'The primary objective is to investigate whether a switch from conventional mechanical ventilation to High Frequency Percussive Ventilation is associated with a change of the SctO2. Therefore, a comparison of SctO2-values two hours before and four hours after the switch will be made.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients at the Intensive Care Unit (ICU)']}, 'descriptionModule': {'briefSummary': 'Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma and postoperative complications. In an attempt to preserve or increase the oxygenation, conventional mechanical ventilation is initiated in these patients. Unfortunately, patients frequently become refractory to standard ventilatory techniques and as such, gas exchange remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the other hand, is an advanced mode of ventilation which can be a salvage option in these patient cohorts as it has already been proven to improve gas exchange with success. The volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially available system to deliver HFPV. This ventilator mechanically ventilates the lung by administering small successive subtidal volumes or percussions at unconventional high frequencies to reach an optimal diffusive oxygenation.\n\nSince it has been known that hypoxemia due to a reduced oxygenation results in secondary brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range has an ameliorative influence on hypoxic events and in turn leads to a better clinical outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation by means of a switch to HFPV automatically leads to an increment in the cerebral tissue oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will investigate whether this alternation of ventilation strategy is associated with a (beneficial) change of the cerebral tissue oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients with COPD (chronic obstructive pulmonary disease)\n* Patients with asthma'}, 'identificationModule': {'nctId': 'NCT02545803', 'briefTitle': 'The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'The Effect of High Frequency Percussive Ventilation on Cerebral Tissue Oxygenation', 'orgStudyIdInfo': {'id': 'VDR4_ZOL1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study group', 'description': 'Adult patients (age ≥ 18 years) at the Intensive Care Unit (ICU) who become refractory to conventional mechanical ventilation and are switched to HFPV.', 'interventionNames': ['Device: Near-Infrared Spectroscopy (NIRS)']}], 'interventions': [{'name': 'Near-Infrared Spectroscopy (NIRS)', 'type': 'DEVICE', 'description': 'Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Ward Eertmans, drs.', 'role': 'CONTACT', 'email': 'ward.eertmans@uhasselt.be'}, {'name': 'Frank Jans, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ward Eertmans, drs', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cathy De Deyne, prof. dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascal Vanelderen, prof. dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Willem Boer, dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ward Eertmans, drs.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'centralContacts': [{'name': 'Ward Eertmans, drs.', 'role': 'CONTACT', 'email': 'ward.eertmans@uhasselt.be'}, {'name': 'Frank Jans, prof. dr.', 'role': 'CONTACT', 'email': 'frank.jans@zol.be'}], 'overallOfficials': [{'name': 'Frank Jans, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg, Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'prof. dr. Frank Jans', 'investigatorAffiliation': 'Hasselt University'}}}}