Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-28 @ 9:10 PM
Study NCT ID:
NCT03947060
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Alternative Position for the SedLine® Sensor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-15', 'size': 1216261, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-07T08:58', 'hasProtocol': True}, {'date': '2019-03-15', 'size': 379460, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-08T15:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values', 'timeFrame': 'One year', 'description': 'Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depth of anesthesia', 'SedLine® sensor', 'Alternative position'], 'conditions': ['Depth of Anesthesia Monitoring']}, 'descriptionModule': {'briefSummary': "SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.\n\nWhenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .\n\nNumerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.", 'detailedDescription': 'The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.\n\nThe hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.\n\nThe primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)\n\nOther parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For each of the two modes of measurement, 1800 data points per subject (1 reading every 2 seconds for 1 hour) per hour will be collected. Assuming a maximum interclass correlation coefficient of .90, a sample size of 40 patients will be required to test the null hypotheses that the two modes of measurement share 95% of their variance via the construction of a 95% confidence interval that ranges no more than +/-5%.\n\nData from the 2 placements will be compared and analyzed using a Bland-Altman analysis, a Scatter plot analysis, and a matched-pair analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years of age, both genders.\n* Patients undergoing simple or complex surgery.\n* American Society of Anesthesiologists Classification (ASA) score I to III.\n\nExclusion Criteria:\n\nAmerican Society of Anesthesiologists Classification (ASA) score IV and V.\n\n* Emergency cases\n* Cognitive/Mentally impaired or unable to provide consent\n* Previous neurological problems affecting EEG\n* Dementia\n* Use of sedative or drugs that can alter EEG readings\n* Patients under head and neck surgery'}, 'identificationModule': {'nctId': 'NCT03947060', 'briefTitle': 'The Alternative Position for the SedLine® Sensor', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland Clinic Abu Dhabi'}, 'officialTitle': 'BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'A-2019-028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nasal & Frontal sensor position', 'description': 'One group of participants with two modes of measurement. First mode is standard frontal placement of the SedLine® sensor. Second mode is alternative nasal placement of the SedLine® sensor.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Cleveland Clinic Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Boris Tufegdzic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Abu Dhabi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland Clinic Abu Dhabi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masimo Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst Prof Dr Boris Tufegdzic', 'investigatorFullName': 'Boris Tufegdzic', 'investigatorAffiliation': 'Cleveland Clinic Abu Dhabi'}}}}