Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 4:07 PM
Study NCT ID:
NCT05693961
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2023-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of SpO2', 'timeFrame': '1 day', 'description': 'Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxygen Saturation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32521167', 'type': 'BACKGROUND', 'citation': 'Luks AM, Swenson ER. Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance. Ann Am Thorac Soc. 2020 Sep;17(9):1040-1046. doi: 10.1513/AnnalsATS.202005-418FR.'}, {'pmid': '31689414', 'type': 'BACKGROUND', 'citation': 'Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.'}, {'pmid': '29176802', 'type': 'BACKGROUND', 'citation': 'Andres-Blanco AM, Alvarez D, Crespo A, Arroyo CA, Cerezo-Hernandez A, Gutierrez-Tobal GC, Hornero R, Del Campo F. Assessment of automated analysis of portable oximetry as a screening test for moderate-to-severe sleep apnea in patients with chronic obstructive pulmonary disease. PLoS One. 2017 Nov 27;12(11):e0188094. doi: 10.1371/journal.pone.0188094. eCollection 2017.'}, {'pmid': '17322018', 'type': 'BACKGROUND', 'citation': 'Shiao SY, Ou CN. Validation of oxygen saturation monitoring in neonates. Am J Crit Care. 2007 Mar;16(2):168-78.'}]}, 'descriptionModule': {'briefSummary': 'A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults aged 20-50 years2\n* COHb \\< 3 %\n* MetHb \\< 2 %\n* ctHb \\> 10 g/dl\n* Non-smoker\n* An individual deemed fit by the investigators to be included in the clinical trial\n\nExclusion Criteria:\n\n* History of respiratory disease\n* History of cardiovascular disease\n* Smoker\n* Pregnant\n* History of fainting\n* History of diabetes\n* Obesity (defined as BMI \\> 30 kg/m2)\n* Allen's test positive (poor collateral blood supply of hand)\n* An individual who is judged to be difficult for the collection of normal PPG signals because CART-I is loose when being worn on fingers other than the thumb and little finger"}, 'identificationModule': {'nctId': 'NCT05693961', 'briefTitle': 'An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sky Labs'}, 'officialTitle': 'An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '2021-0153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CART-I plus', 'description': 'CART-I pulse oximeter with a ring-type wearable PPG sensor was placed on each volunteer to evaluate the SpO2 accuracy during steady-state, non-motion conditions.', 'interventionNames': ['Device: CART-I plus']}], 'interventions': [{'name': 'CART-I plus', 'type': 'DEVICE', 'description': "CART-I noninvasively measures the oxygen saturation of blood in a local area by screening the bloodstream through the user's finger using PPG signals", 'armGroupLabels': ['CART-I plus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'state': 'Pangyo', 'country': 'South Korea', 'facility': 'Sky Labs', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Byung-Moon Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sky Labs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}