Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-04 @ 8:12 PM
Study NCT ID:
NCT03360656
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transnasal Induction of Normothermia in Febrile Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D005334', 'term': 'Fever'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'channan@cooltechcorp.com', 'phone': '2036856352', 'title': 'Director of Clinical Operations', 'organization': 'CoolTech'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.', 'eventGroups': [{'id': 'EG000', 'title': 'Transnasal Thermal Regulating Device', 'description': 'Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours\n\nTransnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 15, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insufficient cooling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse effects on systemic blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cooling Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transnasal Thermal Regulating Device', 'description': 'Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours\n\nTransnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis for cooling performance will be based on the evaluable populations of subjects who undergo cooling treatment with the COOLSTAT System. Analysis will be performed on treatment initiated and treatment completed populations. Subjects who achieve normothermia (core temperature ≤ 37.5 °C) within 4 hours of starting COOLSTAT treatment and maintain normothermia for the duration of the treatment will be determined to have been treated successfully.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transnasal Thermal Regulating Device', 'description': 'Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours\n\nTransnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transnasal Thermal Regulating Device', 'description': 'Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours\n\nTransnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.93', 'spread': '15.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '30'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-07', 'size': 963761, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-25T14:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2017-11-28', 'resultsFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-25', 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cooling Performance', 'timeFrame': '4 hours', 'description': 'Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['shivering, fever, normothermia'], 'conditions': ['Stroke, Ischemic', 'Stroke Hemorrhagic', 'Fever', 'Seizures', 'Metabolic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '37498457', 'type': 'DERIVED', 'citation': 'Arnold S, Armahizer M, Torres LF, Tripathi H, Tandri H, Chang JJ, Choi HA, Badjatia N. Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. Neurocrit Care. 2023 Dec;39(3):639-645. doi: 10.1007/s12028-023-01793-3. Epub 2023 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Admitted to the Neurosciences Critical Care Unit (NCCU).\n2. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.\n3. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.\n4. Planned stay in NCCU \\> 24 hours.\n5. Must have informed consent from the patient or the legally authorized representative (LAR)\n\nExclusion Criteria:\n\n1. Age \\< 18 years old or \\> 95 years.\n2. Intubation is contraindicated.\n3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.\n4. Hemodynamic instability, including elevated SPB for \\>5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).\n5. History of cryoglobulinemia.\n6. History of sickle cell disease.\n7. History of serum cold agglutinin disease.\n8. Active/ongoing of nose bleeds.\n9. Known or suspected pregnancy.\n10. Participation in another ongoing investigational study.\n11. Prisoners and/or patients for whom no LAR is available.\n12. Patient is in airborne/droplet disease isolation protocol.\n13. Patient is or suspected to be immunocompromised;\n14. Low platelet count defined as \\< 100k (thrombocytopenia).\n15. Nasal septal deviations (per CT scan; any degree).\n16. Chronic rhinosinusitis.\n17. Prior skull-based surgery\n18. Penetrating cranial trauma.\n19. Recent nasal trauma or anterior base skull fracture.\n20. Presence of cardiac arrhythmias including: sustained tachycardia defined as heart rate above 120 beats per minute, or sustained bradycardia defined as heart rate below 60 beats per minute.\n21. Refractory hypoxemia defined as partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.60.\n22. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.\n23. History of cardiac arrhythmia as listed above.\n24. BMI of ≤ 15 kg/m2 or ≥ 40kg/m2'}, 'identificationModule': {'nctId': 'NCT03360656', 'briefTitle': 'Transnasal Induction of Normothermia in Febrile Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoolTech LLC'}, 'officialTitle': 'Transnasal Induction of Normothermia in Febrile Stroke Patients', 'orgStudyIdInfo': {'id': 'HP-00074620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transnasal Thermal Regulating Device', 'description': 'Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours', 'interventionNames': ['Device: Transnasal Thermal Regulating Device']}], 'interventions': [{'name': 'Transnasal Thermal Regulating Device', 'type': 'DEVICE', 'description': 'Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours', 'armGroupLabels': ['Transnasal Thermal Regulating Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Neeraj Badjatia, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ of Maryland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoolTech LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}